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

Sr. Clinical Research Associate

Posted: July 23, 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.

 

 

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Clinical Database Specialist

Posted: July 23, 2019

Current Location: Hayward, CA

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Summary:

The Clinical Database Specialist will collaboratively support other functional areas within Pulse and external vendors to ensure data collection are managed appropriately and organized accordingly in a quick and efficient timely manner.  Manage all clinical site photos.

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.

  • Manage and maintain photo database
  • Create and run data reports on periodic basis
  • Expand and modify systems to better serve the needs of Pulse Biosciences
  • Develop programs and databases to assist clinical staff in accurately capturing and recording photos, documents, and reports from site visits
  • Consolidate data from multiple systems into a single archive
  • Handle projects through full data management study life cycle
  • Support project timelines and quality to determine resource needs and out of scope work
  • Conduct data management tasks for data review, writing and learning data clarifications
  • Review data, generate, and resolve data queries
  • Inform Clinical Data Manager on project status and potential problems regularly
  • Identify and comply with working instruction and core operating procedures
  • Handle external vendor application to ensure vendor quality service after initial setup
  • Support Clinical Data Manager in closeout activities such as audit and listing review
  • Support, mentor and train internal employees and clinical sites

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.

  • BA/BS required;
  • 2+ years of clinical data management experience
  • Experience working closely with vendors to make system changes as necessary
  • 2+ years' experience in clinical data management systems (e.g., DAM, ClinCapture, SimpleTrials);
  • Knowledge of CDISC/CDASH, GCMP and implementation of SDTM standards;
  • Knowledge of clinical research industry, biology, chemistry, toxicology, pharmacy, public health or related discipline;
  • Proficient in MS Office Suite
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Engineering

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. User Interface Engineer

Posted: June 20, 2019

Current Location: Hayward, CA

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POSITION SUMMARY:

The Senior User Interface (UI) Software Engineer will be responsible for specifying and developing novel UI software to control a medical device that uses high-voltage nanosecond pulses as treatment. The position will be part of the Research and Development team with responsibility for a wide variety of tasks. The successful candidate will work from requirements and develop, test, and document User Interfaces, encompassing embedded system GUIs and other UI modalities, such as audible prompts, handpiece indicators, pushbuttons, etc. This is a critical role in an early-stage startup environment with a small R&D team. The ideal candidate will have a strong background in UI software design, development, test methodologies using Qt/QML on QNX, Linux, Unix-like operating systems. Experience with medical device quality systems and design control will be a big plus. He or she will engage on any and every issue necessary to ship products to customers of the highest quality and reliability.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Design, development and integration of the Graphical User Interface (GUI) using Qt and QML for medical device.
  • Assist in development of detailed software specifications and provide accurate time estimates for the software development.
  • Design, develop, implement, test, and debug real time, multi-threaded, multiprocessing software applications and associated User Interfaces.
  • Expand knowledge of product domain, requirements, design, development, test and release software processes, tools, methods and coding best practices. A primary emphasis on taking technical ownership of multiple system components that are UI related.
  • Product software sustaining development and enhance existing software products as necessary.
  • Contribute to software requirements definition and creation of Software Specifications and Software Design and Architecture Descriptions.
  • Participate in cross-functional team efforts in definition, integration, verification, and validation of products and sub-systems of moderate complexity.
  • Identify the root causes of issues in complex software or systems using appropriate debug and analysis tools.
  • Timely escalation and documentation of technical software issues to project leadership.
  • 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.
  • Comply with company policies/procedures.

EDUCATION/EXPERIENCE and 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. 

  • 5+ years developing UI Software using Qt and QML for complex UIs.
  • Master’s degree in computer science, software engineering, or a related field and 5+ years of experience.
  • Bachelor’s degree in software engineering, or a related field and 7+ years of experience.
  • Extensive experience developing secure networked user-facing applications using C/C++/STL on Unix-like (POSIX-compliant) operating systems.
  • Working knowledge of Unix-like (POSIX-compliant) OSs, especially RTOSs.
  • Experience with the QNX RTOS a big plus.
  • Experience with common scripting languages (Csh/Bash, Python, Javascript, etc.).
  • Familiarity with version control (Git, TFS, Bitbucket, etc), test automation, and issue tracking (e.g. Jira) applications
  • A passion for creating robust and reliable products.
  • Good communication skills, including experience writing software documentation.
  • Excellent analytical, problem solving, and critical thinking skills.
  • Excellent knowledge with software engineering best practices and the software development life cycle (requirements, design, implementation, test, support).
  • Experience developing applications for safety-critical regulated industries (medical, industrial, automotive, aviation, etc.).

 

 

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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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Operations

Manufacturing Engineer

Posted: June 20, 2019

Current Location: Hayward, CA

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Summary

The Manufacturing Engineer is responsible for manufacturing engineering, production, product support, and servicing to achieve world-class results. Responsible for manufacturing engineering and production of both durable and disposable products.

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.

  • Drive manufacturing engineering and work closely with R&D and Quality to effectively transition products to manufacturing; serve as a key representative and contributor on a project development team;
  • Help define operations processes, including hands-on definition of MPIs, TPs, DHRs, etc.;
  • Conduct PFMEA analyses; define and execute process validations;
  • Work with external vendors including contract manufacturers;
  • Contribute to operations initiatives, apply analytical and statistical methods to continually improve quality, reduce cost, reduce cycle time and simplify processes;
  • Ensure compliance with company policies, procedures, and regulatory;
  • Support failure investigations; collaborate closely with cross-functional groups;
  • Collaborate cross-functionally to define product servicing strategy and infrastructure; Establish L1 (service desk) and L2 (break fix) support;
  • Other tasks as requested by management.

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.

  • Bachelor's degree in engineering, manufacturing, industrial engineering, or a related discipline preferred.
  • 3-5 years' experience in one or more disciplines of manufacturing operations (e.g., manufacturing, assembly & test, manufacturing engineering, subcontract, service);
  • 50 percent travel;
  • Medical device experience required;
  • Technical knowledge of assembly and test of electronic equipment;
  • Working knowledge of manufacturing engineering, ERP and PLM systems, quality assurance and lean manufacturing;
  • Must be flexible, detail oriented, and extremely organized, with a positive outlook, enthusiasm, and high energy; ability to thrive in a rapidly-growing, dynamic, drive-for-excellence environment;
  • Demonstrated knowledge of FDA regulations, ISO 9001, ISO 13485, and other national and international regulations and standards;
  • Experience at start-up companies preferred;
  • Controlled environment room (CER) experience preferred;
  • Excellent communication skills; written, verbal and presentation;
  • Microsoft Office (Word, Excel, Project, PowerPoint, Visio) skills;
  • SolidWorks, Adobe Acrobat Professional, Adobe Illustrator, Zebra Printer hardware/software

 

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Sales

Sr. Product Manager, Device

Posted: June 20, 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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