Join Our Team

Pulse Biosciences is always looking to add the best and brightest minds to our world-class company. Our team is best suited for individuals who are creative, forward-thinking, and who approach challenges with an innovative attitude. If this sounds like a fit for you, we encourage you to explore our current career opportunities below:

To apply for a position, send your resume to careers@pulsebiosciences.com.
Principals only; unsolicited candidate submissions from recruiters or third-party agencies will not be accepted.


Clinical

Clinical Trials Assistant

Posted: December 3, 2020

Company Location: Hayward, CA

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Pulse Biosciences (Nasdaq: PLSE) is a bio-electric medicine company committed to health innovation that has the potential to improve and extend the lives of patients.  The CellFX® System will be the first commercial product to harness the distinctive advantages of our proprietary Nano-Pulse Stimulation™ (NPS™) technology. The unique cell-specific effects of the NPS mechanism of action have the potential to significantly benefit patients across multiple medical applications, including dermatology, our first planned commercial application.

We exist to make a positive difference in the lives of patients, physicians, healthcare providers, shareholders and our Pulse Biosciences team members.  We take pride in hiring the best and brightest minds to our world-class company.  Individuals who are creative, forward-thinking, and who approach challenges with an innovative attitude will excel in our culture. 

 

Position Summary

The Clinical Trial Assistant (CTA) will provide logistical and administrative support to the Clinical Research team.  This position requires basic knowledge of clinical regulatory requirements and clinical trials, excellent organizational skills, and the ability to perform at high levels in a fast-paced, dynamic environment.

Essential Duties and Responsibilities

  • Assist in generation of study start up materials and support feasibility study activities.
  • Participate in the design and implementation of case report forms, CRF and completion guidelines, and database testing.
  • Maintain clinical study and subject schedules; Collaborate with team lead on subject tracking to ensure protocol compliance.
  • Maintain and organize clinical study documents and reference materials related to the indication.
  • Able to review data within the EDC and photography management systems, perform and collate data downloads, reports, and prepare summaries of data extractions for review.
  • Collaborate with CRAs and Data Management on data cleaning, tracking and data analysis quality.
  • Assist team members with designated administrative tasks in support of clinical trial execution and management.
  • Perform study tracking via CTMS or Sponsor designated system to ensure that the study files are current, accurate and complete with applicable local regulatory requirements and ICH/GCP guidelines.
  • Assist in the production of slides for project, departmental, sponsor and/or business development presentations.
  • Actively order and maintain ancillary clinical study supplies required for conduct of clinical trials.
  • Assist with preparation, shipping, handling, distribution, and/or accountability of clinical trial supplies.
  • Follow up with sites for trial invoices and ensure CTMS is accurately updated to allow the timely processing of Investigator Payments.
  • Contribute to the development of clinical trial management best practice processes and SOPs.
  • Maintain up-to-date knowledge of current regulations and guidelines to ensure compliance.
  • Solve routine problems of limited scope and complexity following established policies and procedures.
  • Work collaboratively with team to solve more complex issues.
  • May perform other duties as assigned.

Education and Experience

  • Bachelor's degree or equivalent combination of education and related work experience.
  • One or more years medical device experience, experience in a health science or engineering field.

Skills, Abilities, and Other Requirements

  • Highly proficient in Microsoft Office applications of Word, Excel, and PowerPoint.  Knowledge of relational databases, intermediate statistical analysis, or coding platforms, such as Matlab, is a plus.
  • Basic knowledge of clinical regulations and guidance including GCPs, and ICH guidelines.
  • Excellent organizational skills, ability to manage multiple tasks and meticulous attention to detail.
  • Positive attitude; Able to work under tight timelines.
  • Ability to travel up to 15% of the time.
  • Ability to lift 10-15 pounds.

Our corporate headquarters is located in Hayward, California.  To learn more about us, visit our website at www.pulsebiosciences.com.

At Pulse Biosciences, we are committed to providing a respectful work environment to our diverse workforce.  We provide equal employment opportunities (EEO) to all persons regardless of race, age, color, gender, sexual orientation, national origin, physical or mental disability, religion, or any other characteristic protected by federal, state or local law. We will make reasonable accommodations for qualified individuals with disabilities.

 

Principals only; unsolicited candidate submissions from recruiters or third-party agencies will be considered free referrals.

 

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Senior Manager, Clinical Trials

Posted: November 13, 2020

Current Location: Hayward, CA

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Pulse Biosciences (Nasdaq: PLSE) is a bio-electric medicine company committed to health innovation that has the potential to improve and extend the lives of patients.  The CellFX® System will be the first commercial product to harness the distinctive advantages of our proprietary Nano-Pulse Stimulation™ (NPS™) technology. The unique cell-specific effects of the NPS mechanism of action have the potential to significantly benefit patients across multiple medical applications, including dermatology, our first planned commercial application.

We exist to make a positive difference in the lives of patients, physicians, healthcare providers, shareholders and our Pulse Biosciences team members.  We take pride in hiring the best and brightest minds to our world-class company.  Individuals who are creative, forward-thinking, and who approach challenges with an innovative attitude will excel in our culture. 

 

Position Summary

Pulse Biosciences is seeking a Senior Manager of Clinical Trials to join our dynamic team in our Hayward office. This exceptional leader will be responsible for defining project scopes and estimating budgets, planning, directing, controlling project activities, managing resources and budgets, as well as project team performance of cross-functional teams engaged in clinical research and development activities. This position is also accountable for reporting of project progress status to Pulse Biosciences internal management. These activities may include but are not limited to managing projects with activities focused on clinical operations, data management, statistics, medical writing, subject randomization and study device supply management, administration of data monitoring and adjudication committees, as well as preparing device submissions to regulatory agencies. 

Essential Duties and Responsibilities

  • Manage projects with activities focused on one or more of the following: clinical operations, data management, statistics, medical writing, subject randomization and device supply management, administration of data monitoring and adjudication committees, as well as preparing device submissions to regulatory agencies.
  • Integrate information to define work scopes and estimate budgets, develop and manage cross-functional project work plans including resource requirements and utilization, budgets, quality deliverables and timelines.
  • Manage all project management aspects of assigned Phase I -IV clinical trials and in accordance to ICH/GCP guidelines, FDA, Health Canada, EMA, and other applicable regulatory and legal requirements.
  • Ensure the timely initiation and completion of clinical study projects.
  • Recruit, hire and maintain a high performing Clinical team to drive and achieve Company goals. Lead cross-functional project teams. Manage the planning, implementation, conduct and reporting of assigned projects within the established timelines and budgets, and with the quality and requirements necessary for regulatory approvals.
  • Manage activities between Pulse Biosciences and study sites, and with various supporting groups or thirdparty vendors (e.g., central lab and other specialty labs) to ensure that all contractual obligations are met.
  • Proactively track and manage the financial status against budget and reconcile expenses across sub-streams of activities.
  • Proactively track and manage project tasks against timelines and hours spent/budgets, alert management when there are risks of having major deviations.
  • Prepare project status reports and maintain accurate and current details. Present project status to internal and external stakeholders.
  • Function as meeting facilitator for the meetings involving various internal and external participants.
  • Function as facilitator of problem solving and conflict resolution.
  • Communicate project action items and key decisions through timely minutes and follow up actions.
  • Conduct “lessons learned” meetings with project team members to learn from failures and prevent same from future projects.
  • Contribute and/or participate in the performance evaluation of staff who performed under the responsible projects.
  • This position may assist the organization in responding to and preparing for Request for Information and Request for Proposals for Investigator Initiated Studies, and subsequently defining work scopes and budgets, and performing contract administration activities. 
  • When required, this position may perform clinical trial planning, management, and site monitoring from the initiation of a trial to its closure

Education and Experience

  • Minimum BS / BA (science or healthcare field) or equivalent experience.
  • Minimum of 8 years’ clinical research experience within a medical device, or biotechnology setting.
  • Minimum of 5 years’ project management experience is required.
  • Proven management of overseeing a minimum of 3 Clinical Research Associates for at least 5 years’ is preferred.
  • Experienced as a clinical trial monitor, initiating, monitoring, and closing out clinical trials will be desirable for Clinical Operations support tasks.
  • Demonstrated understanding of cross-functional processes including clinical operations, statistics, data management, subject randomization and device supply management, data monitoring and adjudication committees, regulatory affairs, and medical writing.
  • Knowledge and understanding of ICH/GCP guidelines, FDA, Health Canada, and EMA regulations.
  • Ability to define scopes and estimate budgets, plan and manage projects, including resource requirements and utilization, hours spent vs. budgets, key deliverables and timelines.
  • Demonstrated leadership abilities, including setting goals for others and driving to achieve them in accordance with allocated resources, timelines, and budgets.


Skills, Abilities, and Other Requirements

  • Proficient knowledge and skill in Microsoft Office Suite applications.
  • Excellent interpersonal, oral and written communication skills. Demonstrated strong negotiation and presentation skills.
  • Strong ability in problem-solving including conflict resolution.
  • Ability to work conscientiously and with minimal direction, using good judgment, taking initiative to accomplish short and long-range projects, and recommend actions with minimal direction.
  • Ability to work as a team member, multi-task and be very flexible to adapt to the ever-changing work priorities and requirements of a dynamic, fast growing company.
  • Ability to travel up 35% of the time. Overnight and/or international travel may be required.
  • Ability to lift 10-15 pounds.

Our corporate headquarters is located in Hayward, California.  To learn more about us, visit our website at www.pulsebiosciences.com.

At Pulse Biosciences, we are committed to providing a respectful work environment to our diverse workforce.  We provide equal employment opportunities (EEO) to all persons regardless of race, age, color, gender, sexual orientation, national origin, physical or mental disability, religion, or any other characteristic protected by federal, state or local law. We will make reasonable accommodations for qualified individuals with disabilities.

 

Principals only; unsolicited candidate submissions from recruiters or third-party agencies will be considered free referrals.

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Legal

Legal Counsel

Posted: August 17, 2020

Current Location: Hayward, CA

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Pulse Biosciences (Nasdaq: PLSE) is a bio-electric medicine company committed to health innovation that has the potential to improve and extend the lives of patients.  The CellFX® System will be the first commercial product to harness the distinctive advantages of our proprietary Nano-Pulse Stimulation™ (NPS™) technology. The unique cell-specific effects of the NPS mechanism of action have the potential to significantly benefit patients across multiple medical applications, including dermatology, our first planned commercial application.

We exist to make a positive difference in the lives of patients, physicians, healthcare providers, shareholders and our Pulse Biosciences team members.  We take pride in hiring the best and brightest minds to our world-class company.  Individuals who are creative, forward-thinking, and who approach challenges with an innovative attitude will excel in our culture. 

 

Position Summary

The General Counsel is a member of the Executive Team.  Responsible for advising the Chief Executive Officer, members of the executive leadership team and the Board of Directors on various critical legal and business matters. The General counsel will provide legal advice on contracts, legal risks, and business terms.  He/she will develop a good understanding of the Company’s operations and possess the ability to evaluate and balance both legal and business factors when providing recommendations.  The successful candidate will have a broad knowledge base in areas appropriate for an experienced in-house counsel at a medical device company.

 

Essential Duties and Responsibilities

  • Advise executives, senior management and the Board of Directors on various matters such as legal rights, and new and existing laws.
  • Provide legal advice related to public company reporting and compliance, including SEC rules and regulations and NASDAQ listing standards; handling statutory filings, managing and advising on corporate governance and disclosure matters; maintain corporate records; routine counseling on corporate issues including close interaction with executive management.
  • Provide expert and strategic legal advice to management regarding domestic and international commercialization, including expansion in select geographies.
  • Actively participates in corporate level transactions, including identifying key issues and risks, evaluate new business partnerships with vendors and subcontractors; work closely with other members of the Company’s management team and inform and advise the Company’s Board of Directors as needed.
  • A hands-on approach and attention to detail in performing various duties, including drafting, reviewing, and negotiating various agreements.  Example agreements include domestic and international distribution agreements, specialized product purchase/use agreements with physicians, manufacturing/supply contracts with suppliers of materials or services, clinical trial agreements, professional services agreements, consulting agreements, branding/marketing/PR agreements, joint venture agreements, consents/permissions forms, confidentiality agreements, and other miscellaneous contracts and corporate documents.
  • Advise business managers throughout the contract negotiation process with respect to the areas of legal risk and exposure, while recommending strategies to achieve a satisfactory outcome.
  • Create/modify appropriate template contracts tailored to the business needs; draft agreements that minimize risks and maximize legal rights; manage contract database.
  • Ensure that the Company is compliant with its data protection obligations, including (but not limited to), requests for personal data, DSARs, privacy policies, privacy assessments and data processing agreements.
  • Develop corporate governance, business and compliance policies and practices, enforce policies and regulations in all aspects and levels across the Company.
  • Oversee compliance with corporate governance and the Company’s privacy compliance program, including applicable policies and procedures; participate in training of employees, including field and sales teams.
  • Work closely with the various departments and provide recommendations and comprehensive legal and compliance support where required; guide interdisciplinary teams and management on regulatory issues and health care compliance and provide time and effective legal advice and risk guidance on daily activities; provide risk management and mitigation counseling.
  • Advise on applicable laws, regulations and regulatory guidelines governing commercial and scientific interactions with healthcare professionals, patients, advocacy groups and other business partners, including, but not limited to compliance with Federal and state anti-kickback statutes, False Claims Act, the Food, Drug and Cosmetic Act, HIPAA and product liability law.
  • Preserve all corporate records.  Handle all statutory filings, such as licensing forms.
  • Negotiate, draft, and implement a variety of multi-party agreements including mergers and acquisitions, strategic alliances, and joint ventures.
  • Oversee the selection, retention, management, and evaluation of all outside counsel.
  • Provide overall leadership and management of legal function including leading, mentoring, and developing the legal team.

 

Education and Experience

  • J.D. degree from a national law school and strong academic credentials
  • 10+ years of hands-on legal experience supporting corporate governance issues, corporate and commercial contracting activities and healthcare compliance activities, and corporate secretarial duties
  • Leading law firm and/or in-house medical device/biotechnology/pharmaceutical industry experience is required
  • Active member of the California State Bar or California State Bar eligibility
  • Strong knowledge of contract documents and concepts and strong drafting skills, attention to details is important
  • Understanding of, and experience with, regulatory framework applicable to interactions with healthcare professionals, patient privacy, and related issues
  • Experience in strategic M&A activities.
  • Strong understanding of medical device, biotech or pharmaceutical operations and the ability to create policies and programs that work for the business
  • Great negotiating skill, ability to prioritize, handle multiple tasks and work independently under tight deadlines
  • Proven track record of delivering consistently on complex projects under challenging circumstances with a sense of urgency, but with the ability to also keep broader strategic objectives in focus
  • Ability to communicate effectively both verbally and in writing in both individual and group settings
  • Ability to work calmly under pressure, manage a significant number of projects simultaneously and to thrive in a dynamic and fast paced environment

 

Skills, Abilities, and Other Requirements

  • Proficient knowledge and skill in Microsoft Office Suite applications.
  • Excellent oral written communication skills and critical thinking skills.
  • Ability to work conscientiously and with minimal direction, using good judgment, taking initiative to accomplish short and long-range projects, and recommend actions with minimal direction.
  • Ability to work as a team member, multi-task and be very flexible to adapt to the ever-changing work priorities and requirements of a dynamic, fast growing company.
  • Ability to travel up to 10% of the time.  Overnight and/or international travel may be required.
  • Ability to lift 10-15 pounds. 

Our corporate headquarters is located in Hayward, California.  To learn more about us, visit our website at www.pulsebiosciences.com.

At Pulse Biosciences, we are committed to providing a respectful work environment to our diverse workforce.  We provide equal employment opportunities (EEO) to all persons regardless of race, age, color, gender, sexual orientation, national origin, physical or mental disability, religion, or any other characteristic protected by federal, state or local law. We will make reasonable accommodations for qualified individuals with disabilities.

 

Principals only; unsolicited candidate submissions from recruiters or third-party agencies will be considered free referrals.

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Operations

Receiving and Inventory Coordinator

Posted: January 8, 2021

Current Location: Hayward, CA

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Pulse Biosciences (Nasdaq: PLSE) is a bio-electric medicine company committed to health innovation that has the potential to improve and extend the lives of patients.  The CellFX® System will be the first commercial product to harness the distinctive advantages of our proprietary Nano-Pulse Stimulation™ (NPS™) technology. The unique cell-specific effects of the NPS mechanism of action have the potential to significantly benefit patients across multiple medical applications, including dermatology, our first planned commercial application.

We exist to make a positive difference in the lives of patients, physicians, healthcare providers, shareholders and our Pulse Biosciences team members.  We take pride in hiring the best and brightest minds to our world-class company.  Individuals who are creative, forward-thinking, and who approach challenges with an innovative attitude will excel in our culture. 

 

Position Summary

Performs and coordinates activities related to inventory control such as receiving, expediting, kitting and raw materials storage.  Supports the manufacturing organization relative to raw material, sub-assemblies and operating supplies requirements. 

 

Essential Duties and Responsibilities

  • Coordinates and expedites flow of materials and assemblies between departments, according to production and shipping schedules.
  • Receives all incoming materials (production and non-production) in a timely manner according to SOPs.
  • Works directly with Finance to reconcile related documentation.
  • Maintains raw material inventory integrity in accordance with the part and lot numbering system.
  • Maintains and executes real-time transactions in ERP system.
  • Pull kits / work orders to support internal manufacturing & external Contract Manufacturers.
  • Performs periodic physical inventories and/or maintenance of a cycle count program to ensure inventory accuracy and reporting on same.
  • Support the Shipping department when requested.
  • Maintains the neat and orderly appearance of the company’s inventory storage and warehouse areas.

 

Education and Experience

  • Bachelor’s degree or equivalent preferred.
  • Five (5) years direct functional experience in a medical device environment.

 

Skills, Abilities, and Other Requirements

  • Experience with ERP systems (NetSuite; a plus) commonly used in the medical device field.
  • Experience in a fast-paced start up environment.
  • Understands GMP & ISO job related regulations.
  • Thorough understanding of Fed-Ex shipping procedures.
  • Understanding of International shipping requirements. 
  • Proficient knowledge and skill in Microsoft Office Suite applications.
  • Excellent oral written communication skills with strong analytical and critical thinking skills.
  • Highly organized, detailed oriented, and the ability to be flexible taking on many different tasks.
  • Ability to establish and maintain good working relationships with all functional areas.
  • Ability to work conscientiously and with minimal direction, using good judgment, taking initiative to accomplish short and long-range projects, and recommend actions with minimal direction.
  • Ability to work as a team member, multi-task and be very flexible to adapt to the ever-changing work priorities and requirements of a dynamic, fast growing company.
  • Ability to lift 10-15 pounds.

Our corporate headquarters is located in Hayward, California.  To learn more about us, visit our website at www.pulsebiosciences.com.

At Pulse Biosciences, we are committed to providing a respectful work environment to our diverse workforce.  We provide equal employment opportunities (EEO) to all persons regardless of race, age, color, gender, sexual orientation, national origin, physical or mental disability, religion, or any other characteristic protected by federal, state or local law. We will make reasonable accommodations for qualified individuals with disabilities.

 

Principals only; unsolicited candidate submissions from recruiters or third-party agencies will be considered free referrals.

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Quality/Regulatory Affairs

Senior Quality Engineer, Electrical System

Posted: January 8, 2021

Current Location: Hayward, CA

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Pulse Biosciences (Nasdaq: PLSE) is a bio-electric medicine company committed to health innovation that has the potential to improve and extend the lives of patients.  The CellFX® System will be the first commercial product to harness the distinctive advantages of our proprietary Nano-Pulse Stimulation™ (NPS™) technology. The unique cell-specific effects of the NPS mechanism of action have the potential to significantly benefit patients across multiple medical applications, including dermatology, our first planned commercial application.

We exist to make a positive difference in the lives of patients, physicians, healthcare providers, shareholders and our Pulse Biosciences team members.  We take pride in hiring the best and brightest minds to our world-class company.  Individuals who are creative, forward-thinking, and who approach challenges with an innovative attitude will excel in our culture. 

 

Position Summary

The Senior Quality Engineer will participate in design assurance and production activities of CellFX system in support of the Company’s research and development, manufacturing, regulatory, and clinical affairs efforts.  In addition, this position will support the continual improvement of the quality system processes and compliance activities.

 

Essential Duties and Responsibilities

 

  • Provide expertise and guidance to product development and manufacturing teams in the areas of design assurance with emphasis on electrical system.
  • Proactively investigate CellFX System failure arising from production processes and customer complaint.
  • Actively engage with Electrical Engineering and Manufacturing Engineering to improve system performance, and apply state of the art manufacturing principles to electronic assemblies.
  • Participate in the design verification and validation of CellFX System.
  • Identify and implement effective process control systems to support the development, qualification and on-going manufacturing of products to meet or exceed internal and external requirements.
  • Establish and maintain quality engineering methodologies, systems and practices that meet Pulse Biosciences’ customer and regulatory requirements.
  • Develop and validate measurement methods, monitor design control standards, perform statistical analysis and participate in MRB as appropriate.
  • Design and implement methods and procedures for inspecting, testing and evaluating electronic assemblies and components.
  • Support internal audits and other regulatory compliant activities.
  • Support management review activities, Notified Body audits (ISO), FDA audits and assist with preparation of regulatory submission.
  • Carry out responsibilities in accordance with the organization’s policies and applicable laws.
  • Support the Pulse Biosciences Quality Policy and Quality System.

Education and Experience

  • BS degree in electrical engineering or science field or equivalent.
  • 10+ years of medical device experience.

 

Skills, Abilities, and Other Requirements

  • Must have experience with FDA QSR (21 CFR Part 820 & Part 11) and ISO 13485/MDD requirements.
  • Experience with Medical Electrical Safety and EMC standards (IEC 60601-1, IEC 60601-1-2) and Risk Assessment (ISO 14971: 2012) practices and implementation.
  • Knowledge and experience in the following areas:
    • Design Control
    • Design & Process Validation
    • Risk Management
    • PCB and assembly manufacturing
    • Circuit Design
    • Quality system compliance
    • Complaint handling
    • CAPA management
  • Mastered the use of quality disciplines, tools, and methodologies.
    • Proficient knowledge and skill in Microsoft Office Suite applications.
    • Excellent oral written communication skills, critical thinking skills and project management skills.
    • Ability to work conscientiously and with minimal direction, using good judgment, taking initiative to accomplish short and long-range projects, and recommend actions with minimal direction.
    • Ability to work as a team member, multi-task and be very flexible to adapt to the ever-changing work priorities and requirements of a dynamic, fast growing company.
    • Ability to travel up to 10% of the time.  Overnight and/or international travel may be required.
    • Ability to lift 10-15 pounds.

Our corporate headquarters is located in Hayward, California.  To learn more about us, visit our website at www.pulsebiosciences.com.

At Pulse Biosciences, we are committed to providing a respectful work environment to our diverse workforce.  We provide equal employment opportunities (EEO) to all persons regardless of race, age, color, gender, sexual orientation, national origin, physical or mental disability, religion, or any other characteristic protected by federal, state or local law. We will make reasonable accommodations for qualified individuals with disabilities.

 

Principals only; unsolicited candidate submissions from recruiters or third-party agencies will be considered free referrals.

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Quality Assurance Engineer

Posted: January 8, 2021

Current Location: Hayward, CA

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Pulse Biosciences (Nasdaq: PLSE) is a bio-electric medicine company committed to health innovation that has the potential to improve and extend the lives of patients.  The CellFX® System will be the first commercial product to harness the distinctive advantages of our proprietary Nano-Pulse Stimulation™ (NPS™) technology. The unique cell-specific effects of the NPS mechanism of action have the potential to significantly benefit patients across multiple medical applications, including dermatology, our first planned commercial application.

We exist to make a positive difference in the lives of patients, physicians, healthcare providers, shareholders and our Pulse Biosciences team members.  We take pride in hiring the best and brightest minds to our world-class company.  Individuals who are creative, forward-thinking, and who approach challenges with an innovative attitude will excel in our culture. 

 

Position Summary

The Quality Assurance Engineer will participate in the implementation and maintenance of QSR (21 CFR 820) and ISO 13485 quality systems and qualification activities of CellFX system, disposable and reusable medical devices in support of the Company’s research and development, manufacturing, regulatory, and clinical affairs efforts.  In addition, this position will support the development and implementation of quality systems and compliance activities.

 

Essential Duties and Responsibilities

  • Lead the implementation of quality processes using current PLM system from Arena.
  • Identify and implement effective process control systems to support the development, qualification and on-going manufacturing of products to meet or exceed internal and external requirements.
  • Support internal audits and other regulatory compliant activities.
  • Participate and lead supplier audit of critical suppliers.
  • Perform statistical analysis of key quality processes and participate in MRB as needed.
  • Development of quality procedure in support of quality inspection and testing, and provide training to QC personnel.
  • Monitor Pulse Biosciences Non-conforming (NCR) and Corrective Action (CAPA) compliance activities. Ensure that NCMR and CAPA are appropriately generated, documented, and closed in a timely fashion as defined in established procedure.
  • Support management review activities, Notified Body audits (ISO), FDA audits.
  • Lead UDI and GUDID compliance program to ensure every device is appropriately identified and registered.
  • Carry out responsibilities in accordance with the organization’s policies and applicable laws.
  • Support the Pulse Biosciences Quality Policy and Quality System.

Education and Experience

  • BS degree in science, engineering, or technology field or equivalent experience.
  • Minimum 1-2 years of medical device experience.

 

Skills, Abilities, and Other Requirements

  •  Knowledge and understanding of FDA QSR (21 CFR Part 820 & Part 11) and ISO 13485 requirements.
  •  Knowledge and understanding in the following areas:
    • Quality system compliance
    • Change control
    • Design control
    • Complaint handling
    • CAPA management
    • DHF/DHR review and audit
  • Knowledge of quality disciplines, tools, and methodologies.
  • Proficient knowledge and skill in Microsoft Office Suite applications.
  • Excellent oral written communication skills, critical thinking skills and project management skills.
  • Ability to work conscientiously and with minimal direction, using good judgment, taking initiative to accomplish short and long-range projects, and recommend actions with minimal direction.
  • Ability to work as a team member, multi-task and be very flexible to adapt to the ever-changing work priorities and requirements of a dynamic, fast growing company.
  • Ability to travel up to 10% of the time.  Overnight and/or international travel may be required.
  • Ability to lift 10-15 pounds. 

Our corporate headquarters is located in Hayward, California.  To learn more about us, visit our website at www.pulsebiosciences.com.

At Pulse Biosciences, we are committed to providing a respectful work environment to our diverse workforce.  We provide equal employment opportunities (EEO) to all persons regardless of race, age, color, gender, sexual orientation, national origin, physical or mental disability, religion, or any other characteristic protected by federal, state or local law. We will make reasonable accommodations for qualified individuals with disabilities.

 

Principals only; unsolicited candidate submissions from recruiters or third-party agencies will be considered free referrals.

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Senior Software QA Engineer

Posted: January 8, 2021

Current Location: Hayward, CA

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Pulse Biosciences (Nasdaq: PLSE) is a bio-electric medicine company committed to health innovation that has the potential to improve and extend the lives of patients.  The CellFX® System will be the first commercial product to harness the distinctive advantages of our proprietary Nano-Pulse Stimulation™ (NPS™) technology. The unique cell-specific effects of the NPS mechanism of action have the potential to significantly benefit patients across multiple medical applications, including dermatology, our first planned commercial application.

We exist to make a positive difference in the lives of patients, physicians, healthcare providers, shareholders and our Pulse Biosciences team members.  We take pride in hiring the best and brightest minds to our world-class company.  Individuals who are creative, forward-thinking, and who approach challenges with an innovative attitude will excel in our culture. 

 

Position Summary

The Senior Software QA Engineer will be responsible for quality assurance activities related to software/system development, verification, validation, and overall system functionality and reliability of the CellFX System and accessories in support of the Company’s research and development, manufacturing, regulatory, clinical investigations, and commercial efforts.  In addition, s/he will support the development and implementation of quality systems and regulatory filing activities.

 

Essential Duties and Responsibilities

 

  • Provide expertise and guidance to product development and manufacturing teams in the areas of SW quality assurance, design controls and compliance.
  • Develop, establish and maintain SW quality engineering methodologies, systems and practices that meet the Company’s customer and regulatory requirements.
  • Proactively investigate, identify and implement best-in-class SW quality engineering practices.
  • Identify and implement effective process control systems to support the development, qualification and on-going manufacturing of products to meet or exceed internal and external requirements.
  • Develop and validate SW methods, monitor medical device SW standards, facilitate and perform SW code review. 
  • Assist with preparation of regulatory submissions, regulatory assessments related to software changes and cybersecurity.
  • Development of SW standard operating procedures, SW test methodologies, SW/product trace matrices, and software verification & validation protocols and reports.
  • Design and implement methods and procedures for SW release, SW field upgrade, and final quality assurance.
  • Work closely with the Software Development Team to plan, schedule, and improve development test processes.
  • Work well in a collaborative team environment with other engineers, developers and end users with minimal supervision and ensure understanding and validation of business requirements.
  • Perform validation and verification testing of medical devices and equipment in an FDA regulated environment.
  • Support internal quality audits, management review activities, Notified Body audits (ISO), FDA QSIT audits, and QMS audits by country representatives.
  • Carry out responsibilities in accordance with the organization’s policies and applicable laws.
  • Support the Company’s Quality Policy and Quality System.

Education and Experience

  • BS degree in computer science, software engineering, or computer engineering.
  • 7+ years of hands-on and progressive working experience in the field of SW quality assurance, SW testing, and/or SW development with at least 4+ years working with complex energy-based medical device system (such as Laser, RF, Ultrasound, Microwave, etc.).
  • Experience with various FDA software validation and Cybersecurity guidance’s and IEC 62304 Software Lifecycle process standard requirements are required.
  • Must also have working knowledge and experience in the following areas: Design Control, Design & Process Validation, Risk Management, Cybersecurity, Quality system compliance, Complaint handling, MDR/Vigilance Reporting, and CAPA program.

 

Skills, Abilities, and Other Requirements

  • Familiarity with the use of quality disciplines, tools, and methodologies. 
  • Experience with the following applicable standards and software packages:
    • ANSI/AAMI/IEC 62304:2006 Medical device software –Software life cycle processes.
    • Medical Electrical Safety and EMC standards (IEC 60601-1, IEC 60601-1-2).
    • Risk Assessment (ISO 14971: 2012) including Cybersecurity practices and implementation.
  • Background in software quality assurance, software test development, test methodologies and test automation for native applications built QNX or Similar OS. 
  • Proficient knowledge and skill in Microsoft Office Suite applications.
  • Excellent oral written communication skills, critical thinking skills, and project management skills.
  • Ability to work conscientiously and with minimal direction, using good judgment, taking initiative to accomplish short and long-range projects, and recommend actions with minimal direction.
  • Ability to work as a team member, multi-task and be very flexible to adapt to the ever-changing work priorities and requirements of a dynamic, fast growing company.
  • Ability to lift 10-15 pounds.  

Our corporate headquarters is located in Hayward, California.  To learn more about us, visit our website at www.pulsebiosciences.com.

At Pulse Biosciences, we are committed to providing a respectful work environment to our diverse workforce.  We provide equal employment opportunities (EEO) to all persons regardless of race, age, color, gender, sexual orientation, national origin, physical or mental disability, religion, or any other characteristic protected by federal, state or local law. We will make reasonable accommodations for qualified individuals with disabilities.

 

Principals only; unsolicited candidate submissions from recruiters or third-party agencies will be considered free referrals.

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Sales

Clinical Application Specialist, France

Posted: December 14, 2020

Location: France

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Pulse Biosciences (Nasdaq: PLSE) is a bio-electric medicine company committed to health innovation that has the potential to improve and extend the lives of patients.  The CellFX® System will be the first commercial product to harness the distinctive advantages of our proprietary Nano-Pulse Stimulation™ (NPS™) technology. The unique cell-specific effects of the NPS mechanism of action have the potential to significantly benefit patients across multiple medical applications, including dermatology, our first planned commercial application.

We exist to make a positive difference in the lives of patients, physicians, healthcare providers, shareholders and our Pulse Biosciences team members.  We take pride in hiring the best and brightest minds to our world-class company.  Individuals who are creative, forward-thinking, and who approach challenges with an innovative attitude will excel in our culture. 

 

Position Summary

The Clinical Application Specialist is primarily responsible for long-term customer relationship management and the achievement of utilization-based sales goals for the installed base of CellFX systems within the assigned territory. Reporting to the Director of Sales and Operations – EMEA, the CAP is also responsible for the CellFX installation and practice training, the planning, organization and implementation of account management support, with a high accountability for fostering “Best Practices” for both clinical competency and commercial success.   

Essential Duties and Responsibilities

  • Achieve CellFX system utilization goals in the assigned territory with a focus on utilization growth over time for each installed unit. Responsible for providing comprehensive customer support to drive clinical education and increase procedural growth for the CellFX system for each practice.
  • Provide training, presentations and demonstrations to the customer on clinical applications and proper use of the CellFX system using effective communication and education techniques.
  • Educate the customer on the mechanism of action science of NanoPulse Stimulation, and associated indications, clinical applications, and appropriate safety information of Company’s products and how they fulfill the needs of the customer.
  • Support and help to fulfill the execution of regional training workshops, customer promotional events and tradeshows within the territory and region.
  • Pre-plan sales calls and maintain efficient time management skills to ensure maximum customer contact and highest level of customer service.
  • Develop and maintain up-to-date territory account files in Salesforce.com.
  • Complete administrative responsibilities including periodic business plans, expense reports, up-to-date account profiles and customer database in SFDC.
  • Maintain updated knowledge and expertise of the industry and competitive products.
  • Develop and maintain collaborative and productive relationships at all levels within the organization.
  • Act as liaison between CellFX customer and Company Customer Service and Technical Teams to provide feedback on the CellFX System and its successful clinical and commercial deployment.
  • Participate in industry related tradeshows/meetings.
  • Comply with Pulse Bioscience’s quality system requirements and applicable regulatory requirements.
  • Comply with all Company health and safety regulations, policies and work practices.
  • Maintain consistent communication with Sales Director on all matters related to the territory and region, including accurate forecasting.
  • Other duties as assigned.

Education and Experience

  • Bachelor’s degree or equivalent experience, with a preference for a biology, chemistry, engineering, or related health care background.
  • 4+ years of demonstrated success selling medical products or services to physician’s and/or other health care providers. Preference for direct customer experience with device support to the dermatology and plastic surgery audience.
  • Experience with utilization-based business models in highly preferred. 


Skills, Abilities, and Other Requirements

  • Proficient knowledge and skill in Microsoft Office Suite applications.
  • Ability to communicate effectively, both orally and in writing, to all levels of employees and customers.
  • Multi-lingual preferred, fluency in French and English is essential.
  • Proven ability to provide a high level of customer service and support needed to achieve practice integration of a new technology and ensuring a high level of customer/patient satisfaction.
  • Demonstrate a strong work ethic and always represent the Company with high integrity, ethics, honesty, loyalty and professionalism.
  • Ability to make effective and persuasive communications and technical presentations to physicians, management, and/or large groups.  Ability to thoroughly understand and communicate the attributes and qualities of Company products using professional selling and closing skills.
  • Positive attitude and passion for working within the aesthetic industry.
  • Ability to work conscientiously and with minimal direction, using good judgment, taking initiative to accomplish short and long-range projects, and recommend actions with minimal direction.
  • Ability to work as a team member, multi-task and be very flexible to adapt to the ever-changing work priorities and requirements of a dynamic, fast growing company.
  • Valid driver’s license issued by the country in which the individual resides with a good driving record.  All sales employees are expected to drive a personal vehicle for Company business in good condition and well maintained consistent with the Company’s auto allowance and reimbursement policy.
  • Ability to travel sufficiently to cover entire territory including overnight stays, attend tradeshows and corporate meetings.
  • Home office capability is required with high-speed internet access.
  • Ability to travel up to 60% of the time.  Overnight and/or international travel may be required. 
  • Ability to lift 10-15 pounds.

 

Our corporate headquarters is located in Hayward, California.  To learn more about us, visit our website at www.pulsebiosciences.com.

At Pulse Biosciences, we are committed to providing a respectful work environment to our diverse workforce.  We provide equal employment opportunities (EEO) to all persons regardless of race, age, color, gender, sexual orientation, national origin, physical or mental disability, religion, or any other characteristic protected by federal, state or local law. We will make reasonable accommodations for qualified individuals with disabilities.

 

Principals only; unsolicited candidate submissions from recruiters or third-party agencies will be considered free referrals.

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Clinical Application Specialist, Spain

Posted: December 14, 2020

Location: Spain

read more >

Pulse Biosciences (Nasdaq: PLSE) is a bio-electric medicine company committed to health innovation that has the potential to improve and extend the lives of patients.  The CellFX® System will be the first commercial product to harness the distinctive advantages of our proprietary Nano-Pulse Stimulation™ (NPS™) technology. The unique cell-specific effects of the NPS mechanism of action have the potential to significantly benefit patients across multiple medical applications, including dermatology, our first planned commercial application.

We exist to make a positive difference in the lives of patients, physicians, healthcare providers, shareholders and our Pulse Biosciences team members.  We take pride in hiring the best and brightest minds to our world-class company.  Individuals who are creative, forward-thinking, and who approach challenges with an innovative attitude will excel in our culture. 

 

Position Summary

The Clinical Application Specialist is primarily responsible for long-term customer relationship management and the achievement of utilization-based sales goals for the installed base of CellFX systems within the assigned territory. Reporting to the Director of Sales and Operations – EMEA, the CAP is also responsible for the CellFX installation and practice training, the planning, organization and implementation of account management support, with a high accountability for fostering “Best Practices” for both clinical competency and commercial success.

Essential Duties and Responsibilities

  • Achieve CellFX system utilization goals in the assigned territory with a focus on utilization growth over time for each installed unit. Responsible for providing comprehensive customer support to drive clinical education and increase procedural growth for the CellFX system for each practice.
  • Provide training, presentations and demonstrations to the customer on clinical applications and proper use of the CellFX system using effective communication and education techniques.
  • Educate the customer on the mechanism of action science of NanoPulse Stimulation, and associated indications, clinical applications, and appropriate safety information of Company’s products and how they fulfill the needs of the customer.
  • Support and help to fulfill the execution of regional training workshops, customer promotional events and tradeshows within the territory and region.
  • Pre-plan sales calls and maintain efficient time management skills to ensure maximum customer contact and highest level of customer service.
  • Develop and maintain up-to-date territory account files in Salesforce.com.
  • Complete administrative responsibilities including periodic business plans, expense reports, up-to-date account profiles and customer database in SFDC.
  • Maintain updated knowledge and expertise of the industry and competitive products.
  • Develop and maintain collaborative and productive relationships at all levels within the organization.
  • Act as liaison between CellFX customer and Company Customer Service and Technical Teams to provide feedback on the CellFX System and its successful clinical and commercial deployment.
  • Participate in industry related tradeshows/meetings.
  • Comply with Pulse Bioscience’s quality system requirements and applicable regulatory requirements.
  • Comply with all Company health and safety regulations, policies and work practices.
  • Maintain consistent communication with Sales Director on all matters related to the territory and region, including accurate forecasting.
  • Other duties as assigned.

Education and Experience

  • Bachelor’s degree or equivalent experience, with a preference for a biology, chemistry, engineering, or related health care background.
  • 4+ years of demonstrated success selling medical products or services to physician’s and/or other health care providers. Preference for direct customer experience with device support to the dermatology and plastic surgery audience.
  • Experience with utilization-based business models in highly preferred. 


Skills, Abilities, and Other Requirements

  • Proficient knowledge and skill in Microsoft Office Suite applications.
  • Ability to communicate effectively, both orally and in writing, to all levels of employees and customers.
  • Multi-lingual preferred, fluency in Spanish and English is essential.
  • Proven ability to provide a high level of customer service and support needed to achieve practice integration of a new technology and ensuring a high level of customer/patient satisfaction.
  • Demonstrate a strong work ethic and always represent the Company with high integrity, ethics, honesty, loyalty and professionalism.
  • Ability to make effective and persuasive communications and technical presentations to physicians, management, and/or large groups. Ability to thoroughly understand and communicate the attributes and qualities of Company products using professional selling and closing skills.
  • Positive attitude and passion for working within the aesthetic industry.
  • Ability to work conscientiously and with minimal direction, using good judgment, taking initiative to accomplish short and long-range projects, and recommend actions with minimal direction.
  • Ability to work as a team member, multi-task and be very flexible to adapt to the ever-changing work priorities and requirements of a dynamic, fast growing company.
  • Valid driver’s license issued by the country in which the individual resides with a good driving record. All sales employees are expected to drive a personal vehicle for Company business in good condition and well maintained consistent with the Company’s auto allowance and reimbursement policy.
  • Ability to travel sufficiently to cover entire territory including overnight stays, attend tradeshows and corporate meetings.
  • Home office capability is required with high-speed internet access.
  • Ability to travel up to 60% of the time. Overnight and/or international travel may be required.
  • Ability to lift 10-15 pounds.

 

Our corporate headquarters is located in Hayward, California.  To learn more about us, visit our website at www.pulsebiosciences.com.

At Pulse Biosciences, we are committed to providing a respectful work environment to our diverse workforce.  We provide equal employment opportunities (EEO) to all persons regardless of race, age, color, gender, sexual orientation, national origin, physical or mental disability, religion, or any other characteristic protected by federal, state or local law. We will make reasonable accommodations for qualified individuals with disabilities.

 

Principals only; unsolicited candidate submissions from recruiters or third-party agencies will be considered free referrals.

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