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 GL / Payroll Accountant

Posted: January 15, 2020

Current Location: Hayward, CA

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POSITION SUMMARY

The Senior Accountant is responsible for maintaining accounting policies and procedures that ensure the highest level of efficiency while maintaining appropriate internal controls and compliance with US GAAP. Essential duties and responsibilities are the month-end close process, maintaining the integrity and accuracy of the general ledger, including sub ledger to ledger reconciliations and account reconciliations, roll forwards and monthly / quarterly financial reporting. This position also entails all ownership of payroll functionality. The position operates in fast paced, diverse, and hands-on environment. As the company continues to grow, the Senior Accountant must be able to adapt quickly to meet the changing needs. The ideal candidate will be able to work well independently as well as in a highly collaborative team environment. He/she must be proactive, customer service oriented, ambitious, passionate, adaptable, and flexible.

MAJOR DUTIES AND RESPONSIBILITIES

GL:

  • Prepare monthly journal entries including cash, deferred rent, amortization, depreciation and prepaid.
  • Perform timely and accurate balance sheet reconciliations.
  • Manage accruals, including clinical trial and other R&D accruals.
  • Prepare audit support schedules.
  • Assist with the execution and documentation of internal controls in compliance with SOX 404, including assisting with coordination of internal and external stakeholders.
  • Provide support for the preparation of schedules for forms 10Q and 10K.
  • Make and implement recommendations to improve accounting policies and procedures.

Payroll:

  • Process semi-monthly payroll for 50+ U.S. employees in multiple states, including imputed benefits, gross-up earnings calculations, and earnings from equity transactions
  • Identifying, analyzing and correcting payroll variances
  • Primary point of contact for payroll-related questions with a focus on developing strong relationships throughout the organization
  • Reconcile quarterly and year-end payroll reports and W-2 forms to ensure accuracy
  • Process payroll adjustments to amend quarterly wages and taxes (as needed)
  • Set-up and monitor payroll tax withholding, register and open new payroll tax accounts, and handle tax related correspondence for federal, state, county, and city
  • Ensure payroll file is accurate and complies with appropriate FLSA calculations for regular time, holiday, over-time, PTO.
  • Monitor electronic timesheets for accuracy; communicate with staff and supervisor regarding problems or needed adjustments.
  • Process off-cycle manual checks and adjustments as required.
  • Support the organization in maintaining a work environment focused on quality and that fosters learning, open communication, collaboration, integration and teamwork.
  • Performs other related duties as assigned.

EDUCATION /EXPERIENCE REQUIREMENTS

Bachelor’s degree in finance/accounting or equivalent experience

QUALIFICATIONS:

  • Bachelor’s Degree in Accountancy
  • Minimum 5-7 years of increasingly responsible accounting and reporting experience, preferably with public companies
  • Previous experience with mid-sized ERP systems, preferably NetSuite
  • Computer literacy required, with the ability to navigate computer systems with little or no assistance. Proficiency in MS Office specifically with Outlook, Word, Excel and PowerPoint
  • Must possess the ability to multi-task and work in time sensitive situations to meet deadlines
  • High level of attention to detail, aptitude for planning/managing deadlines
  • Must possess excellent interpersonal communication (oral and written), organizational and project planning skills. Must have ability to effectively work and communicate with all levels of employees throughout the company. Should be customer service driven and have positive outlook.
  • Previous experience in the life sciences, biotechnology or pharmaceutical industry highly desired
  • Ability to self-motivate and function independently, driven towards superior effort and performance, and the desire to work in a very dynamic environment
  • Collaborative and team-oriented.

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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Senior Accounting Manager

Posted: October 8, 2019

Current Location: Hayward, CA

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POSITION SUMMARY

Under the direction of the Controller, the Accounting Manager will oversee accounting functions including GL, journal entries, and other designated tasks. This position is responsible for meeting deadlines and will direct a variety of accounting activities including but not limited to monthly close process, reconciliations and audit preparations.

MAJOR DUTIES AND RESPONSIBILITIES

  • Maintain the general ledger of the company
  • Manage the monthly close process, including preparation/review of journal entries, allocations and account reconciliations
  • Manage accruals, including clinical trial and other R&D accruals
  • Act as the Stock Administrator and record all stock-based compensation expense for stock options, restricted stocks and warrants
  • Assist with the preparation and completion of forms 8-K, 10-Qs, and 10-K
  • Prepare and review audit support schedules
  • Produce monthly financial reporting for the executive team on a timely basis
  • Make and implement recommendations to improve accounting policies and procedures
  • Ensure SOX compliance by monitoring accounting policies, procedures and internal controls
  • Provide technical accounting expertise and knowledge
  • Support the organization in maintaining a work environment focused on quality and that fosters learning, open communication, collaboration, integration and teamwork
  • Performs other related duties as assigned

EDUCATION /EXPERIENCE REQUIREMENTS

Bachelor’s degree in finance/accounting or equivalent experience

QUALIFICATIONS:

  • Big 4 CPA experience
  • 5+ years accounting and reporting experience in public companies
  • Strong understanding of US GAAP and experience with SEC Regulations
  • Previous experience with mid-sized ERP systems, i.e. NetSuite
  • Computer literacy required, with the ability to navigate computer systems with little or no assistance. Proficiency in MS Office specifically with Outlook, Word, Excel (moderate/advanced) and PowerPoint
  • Must possess the ability to multi-task and work in time sensitive situations to meet deadlines
  • High level of attention to detail
  • Must possess excellent interpersonal communication (oral and written), organizational and project planning skills. Must have ability to effectively work and communicate with all levels of employees throughout the company. Should be customer service driven and have positive outlook.
  • Ability to self-motivate and function independently, driven towards superior effort and performance, and the desire to work in a very dynamic environment
  • Collaborative and team-oriented.
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Biology

Associate Research Scientist

Posted: January 3, 2020

Current Location: Hayward, CA

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POSITION SUMMARY:

Under the direction of the Sr. Director I/O Research, 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.

Essential Duties and Responsibilities

This list of duties and responsibilities is not all inclusive and may be expanded to include other duties and responsibilities, as management may deem necessary from time to time.

  • In vivo skills such as handling and treating rodents, tissue sampling, ex vivo post processing of tissues;
  • Conducting survival surgeries on rodents for internal tumor treatments;
  • Design experiments using syngeneic mouse tumor models to optimize the stimulation of the immune system;
  • Conducting in vitro biological techniques, including cell culture and bioassays (i.e. ELISA, Multi-color Flow Cytometry);
  • Has broad understanding and in-depth hands-on experience in evaluating dermatological treatment technologies using in vivo rodent models
  • Has experience to conduct histological analysis of tissues using conventional bright-field microscopy and image analysis of histological slides using electronic slide scanning
  • Review and provide assessments/analysis of scientific studies;
  • Lead role for studies, training, and other projects as needed;
  • Interacting with other functions with interdepartmental projects, project planning, etc.;
  • Give presentations as required;
  • Working closely in teams executing protocols.

Qualifications and 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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • PhD highly desirable, BS w/ 10 years, MS w/ 5 years or PhD w/ 3 years of experience in biological science required ;
  • Five years of relevant experience in medical device, biotech, biomedical, life sciences field; industry experience is highly desirable;
  • Extensive experience generating and treating tumors in vivo in rodents, including survival surgical experience;
  • Flow cytometry experience in panel design, tissue processing, machine operation and analysis
  • Experience with sterile technique, cell culture, standard cellular/molecular biological techniques;
  • Must have experience in planning, understanding, coordinating and running studies independently
  • Excellent verbal and writing skills; experience with MS Outlook, Word, and Excel;
  • Strong interpersonal skills; ability to collaborate and work well in a team environment.
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Associate Research Scientist - Bioelectricity

Posted: December 17, 2019

Current Location: Hayward, CA

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Position Summary:

Under the direction of the Chief Science Officer, conduct in vivo pre-clinical research to optimize tumor clearance efficacy using novel nanosecond pulsed electric field configurations

Essential Duties and Responsibilities

This list of duties and responsibilities is not all inclusive and may be expanded to include other duties and responsibilities, as management may deem necessary from time to time.

  • Programming electronic pulse generators to deliver desired novel pulse parameters to rodent tumors in situ;
  • Modeling expected cellular response to novel pulse parameters using biophysical principles and molecular dynamics;
  • Conducting in vivo biological techniques, including cell culture and tumor cell injection;
  • Using rodent models of syngeneic tumors to evaluate clearance efficacy by novel NPS pulse configurations;
  • Experience conducting histological analysis of tissues with conventional bright-field microscopy including image analysis of scanned slides;
  • Review and provide assessments/analysis of scientific studies;
  • Lead role for studies, training and other projects as needed;
  • Working closely in teams executing protocols;

Qualifications and 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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • BS w/ 10 years, MS w/ 5 years or PhD w/3 years of experience in biophysics or electrical engineering required
  • Five years of experience in medical device, biotech, biomedical, life sciences field; industry experience is highly desirable;
  • Experience with sterile technique, cell culture, standard cellular/molecular biological techniques;
  • Experience generating and treating tumors in rodents, including survival surgical experience;
  • Strong analytical skills and attention to detail;
  • Excellent verbal and writing skills;
  • Strong interpersonal skills; ability to collaborate and work well in a team environment

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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Clinical

Senior Clinical Research Associate

Posted: December 17, 2019

Current Location: Hayward, CA

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POSITION SUMMARY:

The Senior Clinical Research Associate (Sr. 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:

  • Supports investigators with study procedures.
  • Assists in the preparation of clinical study protocols, CRFs, regulatory binders, brochures, and study manuals, and all relevant study documentation.
  • Maintain compliant trial master files of all Pulse Biosciences’ clinical studies and ensure each site is maintaining its regulatory binder as required.
  • Ensure each site is meeting its goals of follow-up rate, data clean deadlines, protocol compliance, and enrollment.
  • Conducts Qualification, Site Initiation, Interim, and Close-Out monitoring visits to orient and train site personnel regarding the protocol and applicable regulatory requirements.
  • Expedites the pre-study and study initiation processes including the conduct of Pre-Study valuation and Site Initiation visits.
  • Performs training of investigators and study coordinators on use of devices and study, as needed.
  • Critically reviews and analyzes site activities through frequent visits and contacts to monitor study sites following the monitoring plan and applicable SOPs, to assure compliance with the protocol, ICH and/or FDA GCP Guidelines and other local regulations. This includes the management of multiple protocols, across therapeutic areas, which may require travel, based upon assigned site location and/or geographic territory.
  • Ensures safety and protection of study subjects according to the monitoring plan, SOPs, and ICH and/or FDA GCP Guidelines.
  • Ensures quality of data submitted from study sites and assures timely submission of data.
  • Supervises overall activities of site personnel over whom there is no direct authority and motivates /influences them to meet study objectives.
  • Anticipates and proactively solves study site problems/issues as they occur. Initiates, recommends and communicates corrective actions as needed.
  • Ensures documented follow-up to all outstanding issues, within the scope of this position profile.
  • Appropriately escalates serious or outstanding issues to line manager and project team members.
  • Facilitates the Regulatory Compliance audit process, as needed.
  • Provides monitoring assistance to site monitor colleagues, as requested, in addition to serving as a mentor to other colleagues as assigned.
  • Proactively communicates and escalates with all internal and external stakeholders any issues identified at study sites while developing the corresponding mitigation strategies and recommended approach.
  • Prepares and submits written reports, both monitoring and administrative, in a timely, accurate, concise and objective manner.
  • Interacts and builds professional and collaborative relationships with all study personnel (study coordinator, investigator, pharmacist), peers, and Sound office-based personnel.
  • Uses multiple technologies to foster, maintain, and enhance open communication
  • Recognize potential obstacles and work to resolve them within set timelines.
  • Monitor emerging industry and regulatory trends to help integrate new requirements into department procedures (i.e. action items, protocol deviations, adverse events, etc.).
  • Complete projects and tasks consistent with corporate objectives.
  • Attend relevant symposia, meetings, and conferences as needed.
  • Support safety monitoring and processes as needed.
  • Participate in department systems and development initiatives including related trainings (i.e. Electronic Data Capture, Clinical Trial Management System, etc.).
  • Perform other duties as assigned by Clinical Affairs 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 of a BA/BS degree in a health-related field with 4 or more years clinical research experience or as a CRA or equivalent.
  • 3+ years Interim monitoring experience required.
  • Medical device experience required. 
  • Strong knowledge of US and international clinical regulations and guidance.
  • Exhibits a high level of flexibility and sets an example for the department when facing changes such as program priorities, protocol modifications, enrollment challenges, etc.
  • Employs good fiscal management to conserve the costs of departmental operation and controls travel expenses.
  • Proficient in Acrobat Adobe, Microsoft Word, Excel, and MS Project; and the ability to quickly become proficient in a variety of other software
  • Excellent oral and written communication skills and critical thinking skills
  • Understanding of medical terminology
  • Ability to perform well-defined procedures and work independently.
  • Ability to exhibit good judgment, be creative, and achieve aggressive goals
  • Ability to make independent decisions and take responsibility within a fast-moving environment.
  • Ability to travel up to 50%. Overnight travel is required; International travel may be required.

COMPANY OVERVIEW:

Pulse Biosciences is a novel medical therapy company bringing to market its proprietary CellFX™ Nano-Pulse Stimulation™ (NPS™) platform. The Company’s CellFX NPS platform provides a novel, precise, non-thermal, treatment technology delivering nanosecond duration energy pulses that impact cells in treated tissue while sparing acellular tissue. NPS’s unique mechanism of action disrupts the functions of internal cell structures while maintaining the outer cell membrane initiating a cascade of events within the cell that results in regulated cell death. The novel characteristics of the Company’s NPS mechanism of action has the potential to significantly benefit patients across multiple medical applications, including dermatology, the Company’s first planned commercial application. In pre-clinical studies, NPS has demonstrated an ability to induce immunogenic cell death in several cancer cell lines. The Company believes its NPS platform may play a role in immuno-oncology as a focal tumor treatment that can initiate an adaptive immune response. More information can be found at www.pulsebiosciences.com.

Pulse Biosciences, Inc. (PLSE, Nasdaq) corporate headquarters is located in Hayward, CA.

CONTACT:

Send resume to:  Careers@pulsebiosciences.com

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Engineering

Principal Mechanical R&D Engineer (Systems)

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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Principal Mechanical R&D Engineer (Disposable Device)

Posted: July 23, 2019

Current Location: Hayward, CA

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POSITION SUMMARY:

Principal Mechanical R&D Engineer will be responsible for leading the developent of disposable and non-disposable medical devices for the delivery of high-voltage nanosecond pulsed electric fields.  Responsibilities include: coming up with new concepts then taking the 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:

  • Leading the design and development of high-volume medical devices which can be manufactured via, stamping, etching, laser cutting/welding, ultrasonic welding, bonding, etc.(desired)
  • Ensure a smooth transition of new products into manufacturing.
  • Manage projects with cross-functional teams following FDA design control processes while generating: requirements/specifications, FMEA/Hazard analyses, design reviews, validation testing, DHFs, etc. 
  • Exhibit a healthy attitude as a team player or leader who excels in a fast-paced start-up environment. 
  • Understand the company’s quality policies and quality system requirements as 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 abilities required. 

  • Extensive mechanical design expertise with laparoscopic or percutaneous disposable and reusable medical devices.
  • Demonstrated experience in managing internal and external development resources and design projects through the complete development cycle from concept through full commercial launch of new medical products following the FDA required design control processes.
  • Strong documentation and project skills required.
  • Experience with Catheter design and development a plus.
  • Comprehensive knowledge of 3-D CAD Solidworks, including drafting standards and GD&T.
  • Intermediate level experience utilizing MS Excel, Word, and Project.
  • Proven track record of generating innovative minimally-invasive concepts that can be turned into manufacturable products. 
  • Fundamental understanding of mechanical engineering theory including: mechanisms, injection molding (required), 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/MS in mechanical engineering required.  Ten years of relevant experience with the medical device industry required.  Startup experience desired.

 

 

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Sr. Mechanical R&D Engineer (Disposable Device)

Posted: January 16, 2019

Current Location: Hayward, CA

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POSITION SUMMARY:

Senior Mechanical R&D Engineer 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.

COMPANY OVERVIEW:

Pulse Biosciences, Inc. is an immuno-oncology company developing a proprietary oncolytic electroceutical therapy based on its Nano Pulse Stimulation (NPS) platform. Preclinical studies using NPS on solid tumors in murine models has demonstrated that NPS enables effective local tumor control and initiates an adaptive immune response with a vaccine-like effect by inducing immunogenic cell death.

Pulse Biosciences, Inc. (PLSE, Nasdaq) corporate headquarters is located in Hayward, CA.

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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Human Resources

Corporate Legal Counsel

Posted: September 24, 2019

Current Location: Hayward, CA

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POSITION SUMMARY:

The Commercial/Contracts and Healthcare Compliance Counsel will work closely with sales, marketing, regulatory affairs and across multiple other internal functional groups and cross-functional teams.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Draft, review, and negotiate various agreements, including domestic and international distribution agreements, specialized product purchase/use agreements with physicians, manufacturing/supply contracts with suppliers of materials or services, professional services agreements, consulting agreements, branding/marketing/PR agreements, joint venture agreements, consents/permissions forms, confidentiality agreements, and other miscellaneous contracts and corporate documents.
  • Work collaboratively with company management and various business units to support commercial and corporate activities.
  • Guide interdisciplinary teams on health care compliance and provide legal advice on daily activities
  • Provide risk management, mitigation counseling
  • Help develop corporate business and compliance policies and practices, participate in field team training and review of promotional materials
  • 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
  • Manage contract database.

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.

EDUCATION and/or EXPERIENCE

  • J.D. degree from a national law school and strong academic credentials
  • 7+ years of hands-on legal experience supporting corporate and commercial contracting activities and healthcare compliance activities
  • 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
  • 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 independently and consistently on complex projects under challenging circumstances
  • Ability to communicate effectively both verbally and in writing in both individual and group settings

 

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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 simultaneously, own deliverables end-to-end, and can thrive in a growing environment. The Business System Administrator/Analyst is responsible for solution engineering, recommending process improvements, evaluating Third-Party tools and implementing enhancements (example: Internationalization) to the NetSuite ERP system, within a SOX compliant environment. Additionally, the Business System Administrator will also partner with the Integration Team for automating interfaces between NetSuite and other key business systems (example: Arena, Engineering Applications, Concur, Salesforce.com). This role is expected to contribute in 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:

  • Collaborate with Finance, Operations, Manufacturing and Engineering to assess business requirements, and to formulate project plans to address these needs using NetSuite and compatible tools.
  • Own end-to-end solution to design, develop, test and deploy NetSuite modules and enhancements build configurable extensions to meet business needs
  • Identify opportunities to improve efficiency and automation for Financial Applications and Processes, which use but not limited to NetSuite
  • Manage requests for new features or functionality, and assist with the prioritization of these requests
  • Effectively work with other technical teams and third-party partners/vendors to successfully integrate NetSuite and related Financial Applications with Engineering applications, Salesforce.com, Concur and other business systems, leveraging best practices.
  • Effectively partner with Managed Services Provider for resolution of production issues
  • Support the Finance departments during the month-end close process
  • Demonstrate strong analytical, problem-solving and communication skills
  • Support corporate SDLC and Change Management processes, in a SOX compliant environment
  • Attitude & work ethic adaptable to change in a fast-paced work environment
  • Exhibit passion about Data Integrity, Data Modelling and Data governance

QUALIFICATIONS:

  • NetSuite Certified – preferably at the Administrator or Consultant level
  • Basic understanding of Accounting Principles and Manufacturing processes
  • 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
  • Experience on third-party tools and boundaries with NetSuite (examples include Revenue Automation, Credit Card Integrations, Expense Management, SOX Automation, Bank Reconciliation, Logistics Automation, etc)
  • Experience with SuiteScript, SuiteFlow, NetSuite Customizations, Saved Searches, Suite Talk
  • Familiarity with using or maintaining SuiteCommerce Advanced module
  • Familiarity with SnapLogic platform is desired, but not required
  • Familiarity using collaborative tools like Smartsheet, Slack, Jira and/or Confluence
  • Project Management Experience is a plus
  • 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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Principal Regulatory Specialist

Posted: December 3, 2019

Current Location: Hayward, CA

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POSITION SUMMARY:

This position will be responsible for global regulatory activities related to the development and implementation of global regulatory strategies to support the submission, filing, and registration of multiple indications (clinical applications or “apps”) in Dermatology and Oncology medical devices in targeted global markets. This role provides leadership in the strategic guidance and execution of regulatory concepts within cross-functional project teams and supports interactions with global health authorities 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, EU MDR (EU 2017/745) and ISO 13485: 2016 QMS, and applicable international regulatory compliance activities.

ESSENTIAL DUTIES AND RESPONSIBILITIES:
  • Develop and implement competitive and effective global regulatory strategies for various Dermatology, General/Plastics and Oncology products including clinical/NSR and identify potential risks associated with proposed strategies
  • Manage all aspects of international regulatory affairs by driving the creation, assembly, compile, review and submission of technical documentation such as Technical Files, Design Dossiers including the General Safety and Performance Requirements (GSPRs) for product CE Marking and post-market follow-ups including amendments/supplements related to clinical trials under the new EU MDR (EU 2017/745)
  • Support FDA regulatory with the creation, review, editing, assembly and submission of domestic FDA regulatory documentation such as 510ks, Pre-subs, Letter-to-Files, IDEs, PMAs, etc. 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 registrations
  • 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
  • Experience with Notified Body, Authorized Representative, Competent Authority and regulatory intelligence activities and clinical registration databases to support product approval strategies.
  • Responsible for adverse event (Vigilance, MDR) reporting and assessments of AE’s to determine “reportable” events. Provide regulatory support as required in the evaluation of product complaints and ensuring AE reports meet regulatory requirements
  • Establish and maintain procedures relating to the MDR/CE Marking processes in accordance with MEDDEV, ISO, and applicable international and country-specific regulatory requirements.
  • Serves as regulatory liaison throughout product development lifecycle.
  • Participates in some of the followings: product plan development and implementation, regulatory strategy, product labeling, risk management, post-market surveillance and post-market follow-up
  • 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.

EDUCATION and EXPERIENCE:

  • Adaptable team player with the ability to work cross-functionality.
  • Bachelor degree in a life sciences, engineering, or technical related discipline.
  • 5 to 8 years of experience in Regulatory Affairs in the medical device or biotechnology industries, including an in-depth knowledge and understanding of the regulatory environment. Dermatology (aesthetics) and/or General/Plastics Surgery regulatory experience preferred.
  • Knowledge of current EU regulations, Notified Body conformity assessment including experience preparing, compiling, filing, and performing life-cycle management of applications and all Technical Documentation format.
  • Experience with health authority meeting preparation.
  • 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 EU MDR 2017/745, ISO 13485: 2016 and FDA QSR regulations.
  • Experienced with both high risk device and non-significant risk device classes (Class III/IIb/IIa/II)
  • Familiar with both FDA Electrosurgical guidance and IEC 60601 Safety requirements.
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Sales

Sr. Product Manager, Device

Posted: November 14, 2019

Current Location: Hayward, CA

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POSITION SUMMARY:

Pulse Biosciences is seeking a passionate, medical device product manager with launch experience. The role of Product Manager covers both upstream and downstream activities. The Product Manager will be responsible for developing marketing strategies and tactics to lead to the future success of Pulse Biosciences in dermatology.  Reports to the Sr. Director of Marketing.  Position is located in Hayward, CA.

ESSENTIAL DUTIES & RESPONSIBILITIES:

  • Partner closely with Engineering/RD/Ops to ensure alignment on technical and business requirements for the realization of products based on end user experience and feedback during the development process.
  • Ensure optimal customer/KOL interaction in the development process. Apply learnings to current and future product releases. Assess/ validate impact of new product concepts including investment needed and expected volume impact.
  • Lead cross-functional teams through all aspects of the product launch process, and measure product success through post-launch product feedback.
  • Serve as champion and subject matter expert on our product - lead/support communication and training for products across the organization.
  • Serve as product trainer for sales and marketing teams
  • Serve as an internal subject matter expert on all clinical and user-experience feedback on the device and application
  • Track competitive products and emerging technology
  • Responsible for product management of device, translating customer/market needs into a compelling product vision and market-changing product solutions/iterations.
  • Create and execute annual operating plan for product, aligning with corporate goals and objectives.
  • Responsible for analysis, planning, and implementation of tactical programs. Monitoring sales forecasts.
  • Craft and refine marketing collateral and training materials that support product positioning
  • Develop sales training materials and selling aids for sales force and customer service. Participate in internal/external training activities.
  • Lead and manage market research projects as needed.
  • Coordinate with marketing communications (internal and external resources) to direct development of launch materials, product literature, POP, brochures, clinical education, video and any other collateral material required to support sales and other corporate needs.
  • Develop national and regional tradeshow calendar, participate in key events; lead efforts including messaging, booth and promotional presence, event logistics, and budget.
  • Capacity to learn new technical skills and build clinical acumen for clear communication in all customer-facing materials.
  • Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
  • Ability to work independently, using good judgment, initiative and analytical abilities, to accomplish short and long-range projects, anticipate likely needs, and recommend actions with minimal direction. Demonstrated time management skills.

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. 

  • 3-5 years technical product management or other relevant experience
  • Proven track record of developing, executing and monitoring marketing plan execution.
  • Demonstrated fiscal performance, meeting top line revenue goals while managing bottom line spend
  • Strategic thinker with ability to link strategy to tactics with faultless execution
  • Excellent writing, verbal communication, analytical and presentation skills.
  • Ability to travel 25% of the time

EDUCATION & EXPERIENCE:

  • BS in BA in Marketing or technical-related field or equivalent.  MBA preferred and a plus.
  • Experience working in the medical device industry is strongly preferred.
  • Experience working in the aesthetic or dermatology industry is strongly preferred.
  • Experience with MS Excel, Word, and Project.

 

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