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.


Accounting/Finance

Senior Manager - Technical Accounting, Compliance, and SEC Reporting

Posted: March 11, 2020

Current Location: Hayward, CA

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POSITION SUMMARY:

Reporting to the Corporate Controller, the incumbent in this position will be responsible for all aspects of SEC reporting, technical accounting research related to new and proposed accounting standards and complex accounting transactions, SOX compliance efforts, coordination and review of quarterly tax provisions, and preparation for, and interaction with, internal and external auditors, as well as tax consultants.  This position also contributes significantly to the quarterly close process, federal and state tax returns and special projects. 

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Perform technical accounting research as needed and prepare memos documenting conclusions and proper accounting treatment.  Interact with external auditors with respect to accounting conclusions reached.
  • Maintain external reporting calendar, including scheduling and coordination of independent auditors, internal auditors for SOX compliance, and tax advisors.
  • Assist in the preparation of audit schedules for quarterly reviews and annual audit.
  • Prepare quarterly Audit Committee materials.
  • Manage the Company’s SOX compliance efforts including maintaining the internal control documentation, implementing new controls as necessary and managing the Company’s external SOX consultants including the coordination of testing and review of the related work papers.
  • Lead the Company in its transition from SOX 404a to 404b compliance.
  • Active role in updating/implementing accounting policies and procedures to respond to changes within the Company and industry, SEC/GAAP regulations and SOX 404 requirements.
  • Manage the external reporting function to ensure the accurate and timely filing of the Company’s SEC and other regulatory reporting requirements, including preparing the documents, managing the internal and external review of the documents and filing of the documents. Includes but not limited to Forms 10-K, 10-Q, 8-K and Section 16 Reporting, as well as the proxy statement. 
  • Manage preparation of the Company's stock-based compensation expense and EPS calculations.
  • Prepare and manage tax provision requirements with external tax partner.
  • Assist in coordination and review of federal and state tax returns.
  • Other special projects as required.
  • Other duties as assigned.

EDUCATION and EXPERIENCE:

  • BA/BS in business, accounting, or related field.
  • CPA license required.
  • 10+ years’ of increasingly responsible accounting and reporting experience.
  • 3+ years’ SEC reporting experience within a public company.
  • 3+ years’ SOX 404 compliance experience, implementation experience a plus.

 

Other Requirements:

  • Highly proficient in Excel, Word and PowerPoint.
  • High level of organization, attention to detail, aptitude for planning/managing deadlines.
  • Maintain confidentiality over all finance and accounting matters and information.
  • Exceptional communication skills, including the ability to effectively present information to various levels of an organization, including the Audit Committee of the Board of Directors.
  • Excellent interpersonal and project management skills with ability to work effectively with multiple functional areas.
  • Strong commitment to a team approach, and awareness of team and individual success dependencies.
  • Ability to successfully manage multiple projects with competing priorities and tight deadlines.
  • Ability in exercising sound judgment and working independently with minimal supervision and/or guidance.
  • Proactive problem solver presents problems and recommendations simultaneously.
  • Self-motivated, highly driven, independent, and results-oriented.
  • Experience with major ERP systems and associated planning and reporting tools.
  • Minimum three years’ in a manufacturing environment, preferably medical device.
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Clinical

Clinical Research Associate

Posted: January 27, 2020

Company Location: Hayward, CA

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POSITION SUMMARY:

The Clinical Research Associates (CRA) is responsible for assigned aspects of clinical monitoring and site management in accordance with the Code of Federal Regulations (CFR) of the Food and Drug Administration (FDA) and the International Conference on Harmonization - Good Clinical Practice (ICH-GCP). Site visits are conducted to assess protocol and regulatory compliance, data reliability, and the proper care and treatment of study subjects. Please note: This is not a remote position.

 

ESSENTIAL DUTIES AND RESPONSIBILITIES:

 

  • Provides case support to research sites across multiple studies.
  • Prepare for, plan, organize and conduct site qualification, site initiation, interim and close-out visits.
  • Completes monitoring reports within two weeks of visit date.
  • Train site staff on therapeutic areas, protocol requirements, study device, proper source documentation and case report form completion.
  • Order, track, and manage investigational product (IP) and trial materials as needed.
  • Oversee and document IP dispensing, inventory and reconciliation.
  • Protect subjects’ confidentiality and verify IP was dispensed and administered according to protocol.
  • Ensure compliance with the patient-informed consent process.
  • Ensure compliance in reporting adverse events/serious adverse events according to the study protocol and applicable regulatory agencies.
  • Ensure compliance with Standard Operating Procedures (SOPs) and local regulations, and ICH, and GCP guidelines.
  • Responsible for the creation and maintenance of the trial master file, regulatory binder, source documents, and photography slides.
  • Regularly update project tracking tools and systems.
  • Support electronic data capture (EDC) user acceptance testing and training as needed.
  • Ensure timely resolution of all data queries remotely or at investigator site.
  • Perform source data verification against CRF/EDC entries in compliance with the Monitoring Plan.
  • Responsible for reviewing data and documents related to study endpoints. 
  • Assist with study report completion.
  • Create adjudication packets under the supervision of study management.

 

QUALIFICATIONS / EDUCATION:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill, and/or ability required. 

  • Minimum BS/BA degree.
  • Minimum 1+ years’ experience directly supporting clinical research or relevant experience in medical/scientific area.
  • Demonstrates working knowledge of GCP, ICH guidelines, ISO Standards, and FDA regulations.
  • Proficient in Acrobat Adobe, Microsoft Word, Excel, Power Point, and the ability to quickly become proficient in a variety of other computer software programs.
  • Experience in using EDC and CTMS systems is desirable.
  • Experience in monitoring clinical trials is desirable.
  • Excellent oral and written communication skills.
  • Excellent record-keeping skills; good documentation practice.
  • Ability to work well in a team environment.
  • Customer focus.
  • Ability to efficiently organize and prioritize work within a multifaceted framework and set deadlines.
  • A pro-active, committed and motivated attitude.
  • Flexibility in work hours and readiness to travel. Travel may be up to 75%.
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Principal Clinical Research Associate

Posted: January 27, 2020

Current Location: Hayward, CA

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POSITION SUMMARY:

 

The Principal Clinical Research Associate (CRA) is an integral member of the Clinical team. This position manages and oversees study site activities to ensure the integrity of clinical data in adherence to all applicable regulatory guidelines and Pulse Biosciences’ operating procedures (i.e. SOPs). This position requires detail-orientation, organization, and a strong desire to learn clinical research processes continuously.  Please note:  This is not a remote position. 

 

ESSENTIAL DUTIES AND RESPONSIBILITIES:

 

  • Provides case support to research sites across multiple studies.
  • Demonstrates strong written and verbal communication skills.
  • Responsible for writing clinical reports, protocols, informed consent, case report forms, study newsletters, and other study-related documents in consultation with the cross-functional project team, data management and biostatisticians.
  • Review data listings and tables for clinical reports.
  • Assist with the conduct of Physician Committees. (e.g. CEC, DSMB, etc.)
  • Responsible for the scheduling and conduct of pre-study visits, initiation visits, interim monitoring visits and close-out visits according to the Monitoring Plan and applicable SOPs, to assure compliance with the protocol, ICH and/or FDA GCP Guidelines and other local regulations.
  • Delivers high quality written trip reports, confirmation and follow-up letters within timelines of SOPs and monitoring plans.
  • May support submission of studies to IRB/IEC and regulatory authorities.
  • Verifies the rights and well-being of study subjects are protected.
  • Verifies that written informed consent was obtained before each subject’s participation in the study.
  • Verifies that the investigator is enrolling only eligible subjects.
  • Verifies the quality of all recorded data. Issues and ensures timely resolution of all data queries remotely or at investigator site.
  • Performs Investigational Product (IP) accountability, including product storage, inventory, return/destruction, and dispensing/receipt records.
  • Verifies and supports the recording and reporting of adverse events/serious adverse events. Ensures all types of adverse events are reported and tracked per regulatory requirements and the Monitoring Plan.
  • Communicates deviations from the protocol, SOPs, and/or GCP, to the investigator, and project management team and takes appropriate action to prevent recurrence.
  • Participates in site audits, as requested.
  • May assist the Clinical Trial Manager with coordination and management of the project budget and project invoicing.
  • Attends and participates in team teleconferences/meetings providing mentoring and training.
  • Provides mentorship, training and direction to Clinical Research Associates.
  • Other duties as assigned by Clinical Trial Manager/Research Manager and per project-specific requirements.

Supervisory Responsibilities: None

QUALIFICATIONS / EDUCATION:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill, and/or ability required. 

  • Minimum BS/BA degree.
  • Minimum 6+ years’ experience directly supporting clinical research or relevant experience in medical/scientific area.
  • Certified as a CRA, e.g. CCRA , CCRP, or other CRA certification strongly preferred.
  • Knowledge of FDA and international regulations and guidelines including, but not limited to, clinical strategy, GCPs, SOPs, submissions, product launch, labeling, advertising and promotion, product vigilance and medical device reporting.
  • Skills to mentor and train other CRAs in a positive and effective manner.
  • High energy and results-oriented individual who is mature and successful in a business environment.
  • Finance and budgeting knowledge.
  • Proficient in Acrobat Adobe, Microsoft Word, Excel, Power Point, and Smartsheet; and the ability to quickly become proficient in a variety of other computer software programs.
  • Proven organizational abilities, and excellent oral and written communication and presentation skills.
  • Strong customer focus.
  • Ability to perform well-defined procedures and work independently with minimal assistance.
  • Ability to make independent decisions and take responsibility within a fast-moving environment.
  • Ability to travel on an average of 50-75%, depending on project needs. International travel may be required.

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Senior Clinical Research Associate

Posted: December 17, 2019

Current Location: Hayward, CA

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POSITION SUMMARY:

The Sr. Clinical Research Associate (CRA) is responsible for management and monitoring activities that will lead to successful execution of clinical studies. The position will monitor patient recruitment, data and study related information related to clinical sites and study participation. Ensures that duties are performed in accordance with the Code of Federal Regulations (CFR) of the Food and Drug Administration (FDA) and the International Conference on Harmonization - Good Clinical Practice (ICH-GCP).

 

ESSENTIAL DUTIES AND RESPONSIBILITIES: 

  • Provides case support to research sites across multiple studies.
  • Responsible for monitoring clinical studies, which includes the review of case report forms (CRFs) or electronic data capture (EDC), and source documentation to ensure adherence to the protocol and scientific validity of the data.
  • Responsible for developing study specific monitoring tools and other related documents as needed.
  • Responsible for reviewing and approving essential regulatory documents across multiple studies.
  • Assists the project team in developing study metrics to ensure the efficient execution of a clinical trial as required.
  • May support submission of trials to IRB/IEC and regulatory authorities.
  • Ensures adherence to study timeline across multiple studies.
  • Coaches and mentors less experienced CRAs and assist in their development and training.
  • Maintains strong working knowledge of protocols and product development across multiple studies.
  • Prepare and develop project and study-related documents including informed consent forms, CRFs, study guides, study reference binders, and patient diaries, as required.
  • Coordinate review of data listings and preparation of interim/final clinical study reports.
  • Delivers high quality written monitoring reports, confirmation and follow-up letters within timelines of SOPs and monitoring plans.
  • Demonstrates ability to coordinate, organize, communicate, and manage site activities, with knowledge of when to escalate issues to management or clinical team.
  • Demonstrates an excellent working knowledge of clinical research processes, Good Clinical Practices, International Committee on Harmonization Guidelines, federal regulations and applicable local laws pertaining to clinical research investigations.
  • Verifies the rights and well-being of study subjects are protected and verifies that written informed consent was obtained before each subject’s participation in the study.
  • Performs Investigational Product accountability, including product storage, inventory, return/destruction, and dispensing/receipt records.
  • Ensure compliance in reporting adverse events/serious adverse events according to the protocol and applicable regulatory agencies.
  • May manage Protocol Deviation documentation, tracking, and escalation.
  • Participates in site audits, as requested.

 

 

QUALIFICATIONS / EDUCATION:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill, and/or ability required. 

  •  Minimum BS/BA degree.
  • At least 3 years clinical research experience as a monitor in the pharmaceutical, biotechnology or CRO industry.
  • Certified as a CRA, e.g. CCRA, CCRP, or other CRA certification strongly preferred.
  • Proficient in Acrobat Adobe, Microsoft Word, Excel, Power Point, and the ability to quickly become proficient in a variety of other computer software programs.
  • Proficient in using EDC and CTMS.
  • Working knowledge of FDA, European Regulatory and CE procedures, as applicable.
  • Exhibits a strong knowledge base of medical terminology and pathophysiology.
  • Ability to organize and take initiative.
  • Excellent analytical skills.
  • Clear and systematic thinking that demonstrates good judgment and problem-solving competencies.
  • Excellent oral and written communication and presentation skills.
  • Ability to work independently with minimal oversight as well as actively contribute to a project team.
  • Flexibility in work hours and readiness to travel. Travel may be up to 75%.
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Engineering

Senior Mechanical R&D Engineer

Posted: September 24, 2019

Current Location: Hayward, CA

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POSITION SUMMARY:

Senior Mechanical R&D Engineer (Systems) will be responsible for developing disposable and non-disposable medical devices for the delivery of high-voltage nanosecond pulsed electric fields. Responsibilities include: taking concepts from early prototypes to volume production, working closely with surgeons to obtain design feedback in a surgical environment, and developing close ties with new vendors. You will play a critical role in an early-stage startup environment with a small R&D team.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Design and develop high-volume medical devices that can be manufactured via injection molding, stamping, etching, laser cutting/welding, ultrasonic welding, bonding, etc.
  • Ensure a smooth transition of new products into manufacturing.
  • Manage projects with cross-functional teams following design control processes while generating: requirements/specifications, FMEA/Hazard analyses, design reviews, validation testing, DHFs, etc. 
  • Exhibit a great attitude as a team player who excels in a demanding start-up environment. 
  • Understand the company’s quality policy and quality system requirements applicable to tasks.

QUALIFICATIONS:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill, and/or ability required. 

  • Extensive mechanical design expertise with laparoscopic or percutaneous disposable and reusable medical devices.
  • Experience with Catheter design and development a plus.
  • Comprehensive knowledge of 3-D CAD, including drafting standards and GD&T.
  • Intermediate experience with MS Excel, Word, and Project.
  • Proven track record of generating innovative minimally-invasive concepts that can be turned into manufacturable products.
  • Demonstrated experience in managing internal and external development resources to achieve product development goals.
  • Fundamental understanding of mechanical engineering theory including: mechanisms, strength of materials, materials, adhesives, and high-volume manufacturing techniques. Understanding of electronics and circuits a plus.
  • Previous experience in ensuring a smooth transition to manufacturing.
  • Strong work ethics with a team-oriented mindset.

EDUCATION and/or EXPERIENCE

  • BS or MS in mechanical engineering required.  Five years of relevant experience in medical device industry required.  Startup experience a plus.

 

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IT

NetSuite Administrator/Analyst

Posted: December 18, 2019

Current Location: Hayward, CA

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POSITION SUMMARY:

Pulse Biosciences is seeking an experienced NetSuite Business System Administrator/Analyst to join the IT team out of our Hayward office. You are right for this role if you consider yourself a self-starter; someone who is able to manage multiple tasks and projects in NetSuite simultaneously, own deliverables end-to-end, and can thrive in a fast-paced environment. The Business System Administrator/Analyst is responsible for solution engineering, recommending process improvements and implementing enhancements to the NetSuite ERP system, while adhering to a SOX and IT Change Management processes. The ideal candidate has the potential to be converted from contract into Full-Time, and advance his/her contributions towards optimizing and automating the company's financial applications landscape over the next few years by implementing and supporting scalable business processes to support company's growth and initiatives.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Serve as a primary NetSuite SME for implementing changes for SOD Controls, Analysis Monitoring and Mitigation project, using FastPath or similar tool.
  • User Provisioning, Saved Searches, Reports, Day-today Administrative functions
  • Sandbox Refreshes
  • Assist with ITGC reports for SOX compliance
  • Support core NetSuite Users of Finance, Inventory, Procurement and Manufacturing business functions.
  • Support SOD requirements for Production Changes, using the Change Management guidelines
  • Manage requests for new features or functionality, and assist with the prioritization of these requests
  • Effectively partner with Integration Team and Managed Services Provider for resolution of production issues.
  • Support the Finance departments during the month-end close issues and process
  • Demonstrate strong analytical, problem-solving and communication skills
  • Attitude & work ethic adaptable to change in a fast-paced work environment
  • Exhibit passion about Data Integrity, Data Modelling and Data governance

QUALIFICATIONS:

  • NetSuite Certification is highly desired
  • Basic understanding of Accounting, Costing and Manufacturing Configurations within NetSuite
  • Expertise on Record-to-Report, Procure-To-Pay, Order-To-Cash, Manufacturing processes within NetSuite
  • Knowledge or experience of SuiteCommerce Advanced will be a big advantage, but not a requirement
  • Experience supporting or implementing third-party tools, SuiteApps, and/or boundaries with NetSuite (examples include Revenue Automation, Credit Card Integrations, Expense Management, SOX Automation, Bank Reconciliation, Logistics Automation, etc)
  • Familiarity with SuiteScript, SuiteFlow, NetSuite Customizations, Saved Searches, Suite Talk
  • Familiarity with SnapLogic platform is desired, but not required (this is not a developer role)
  • Experience using collaborative tools like Smartsheet, Slack, Jira and/or Confluence
  • Is a NetSuite Community Enthusiast and Contributor

EDUCATION and EXPERIENCE:

  • Bachelor’s degree in Engineering or Science
  • 5-6 years hands-on verifiable experience using NetSuite, with atleast three full-scale implementations
  • Overall combined Enterprise Business Applications experience of 8 years
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Quality/Regulatory Affairs

Regulatory Affairs Manager

Posted: December 10, 2019

Current Location: Hayward, CA

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Position Summary:

This position will be responsible for regulatory activities related to the development and implementation of  regulatory strategies to support the submission and filing of multiple indications (clinical applications or “apps”) in Dermatology and Oncology medical device products in targeted markets. This role provides leadership in the strategic guidance and execution of regulatory concepts within cross-functional project teams and supports interactions with FDA and corporate partners with regulatory deliverables. In addition, this position will require direct and hands on experience to support the development and implementation of FDA QSR and ISO 13485: 2016 QMS, and applicable international regulatory compliance activities.Under the direction of Associate Research Scientist, conduct in vitro and in vivo pre-clinical research to optimize the stimulation of the immune system using the Nano-Pulse Stimulation Platform. Conduct additional pre-clinical research where the data indicates further research.

Description:

  • Develop and implement competitive and effective  FDA regulatory strategies for various Dermatology, General/Plastics and Oncology products including clinical/NSR and identify potential risks associated with proposed strategies
  • Manage and participate in the creation, review, editing, assembly and submission of regulatory documentation such as 510ks, Pre-subs, SIRs, Letter-to-Files, IDEs, and PMAs,) including regulatory responses and agency interactions oversees the strategy implementation and operations for directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports
  • Interacts with regulatory agencies to expedite submissions and/or approval of pending regulatory reviews
  • Monitor regulatory outcomes of initial product concepts and provide input to senior regulatory management
  • Assist Clinical operations and ensuring clinical study results and reports are suitable for regulatory submissions
  • Serves as regulatory liaison throughout product development lifecycle
  • Participates in some of the followings: product plan development and implementation, regulatory strategy, product labeling, promotional review, risk  assessment, adverse events (eMDR), field action, etc.
  • Ensure alignment of regulatory strategy to business strategy across all functional area including timely approval of new medical devices and continued expansion approvals of marketed products.
  • Serves as regulatory representative to marketing, clinical, research teams and regulatory agencies.
  • Accountable for ensuring that regulatory submissions, technical documentation meet appropriate standards, guidance, and content requirements.
  • Advises development and/or marketing teams on product changes, line extensions, technical labeling, appropriate regulations and interpretations
  • Write regulatory justifications to support design changes and submission filing decisions
  • Carry out responsibilities in accordance with the organization’s policies and applicable laws
  • Support the Pulse Biosciences Quality Policy and Quality System.

Qualifications/Requirements:

  • Adaptable team player with the ability to work cross-functionality.
  • Bachelor degree in a life sciences, engineering, or related discipline.
  • 5 to 10 years of experience in Regulatory Affairs in the medical device including an in-depth knowledge and understanding of the FDA regulatory environment. Dermatology (aesthetics) and General/Plastics Surgery, regulatory experience preferred.
  • Proven ability to independently manage critical projects as part of an interdisciplinary team. In addition, the candidate should have hands-on experience preparing, managing and submitting major regulatory submissions.
  • Ability to successfully manage multiple projects and navigate challenges to deadlines.
  • Good communication skills in both verbal and non-verbal.
  • Have solid understanding and proving practices within both FDA QSR regulations and ISO 13485: 2016 quality system management
  • Experienced with both high risk device and non-significant risk device classes (Class III/IIb/IIa/II)

Send resume to:  careers@pulsebiosciences.com

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, national origin, protected veteran status, or on the basis of disability, gender identity, and sexual orientation.

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