Pulse Biosciences, Inc. · 3 days ago
Sr. Quality Engineer
Hayward, CA
Full-time
Onsite
Senior Level
$115K/yr - $140K/yr
5+ years expPulse Biosciences is a novel bioelectric medicine company committed to health innovation. As the Sr. Quality Engineer, you will implement and maintain quality systems for medical devices while providing expertise to product development and manufacturing teams.
Health CareMedicalMedical DeviceTherapeutics
Responsibilities
Provide expertise and guidance to product development and manufacturing teams in the areas of design assurance, design controls and compliance
Develop, establish, and maintain quality engineering methodologies, systems and practices that meet Pulse Biosciences’ customer and regulatory requirements
Lead the risk management process in establishing risk management plan, conducting risk evaluation and analysis, and creating risk management report
Lead the process in establishing product traceability matrices, conducting requirement trace verification and analysis, and creating trace matrix reports
Manage all aspects of biocompatibility testing and sterilization including creating of test protocols and executing of testing
Proactively investigate, identify, and implement best-in-class quality engineering practices
Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements
Develop and validate measurement methods, monitor design control standards, facilitate, and perform statistical analysis, and participate in MRB as appropriate
Lead the review of process and product quality performance, working in concert with various departments
Assist with development of product labeling, UDI compliance, translation, and investigator brochures for commercial and clinical studies
Design and implement methods and procedures for inspecting, testing, and evaluating components, sub-assemblies, and final assemblies
Support management review activities, regulatory audits including Notified Body audit (MDSAP) and assist with preparation of regulatory submissions
Carry out responsibilities in accordance with the organization’s policies and applicable laws
Support the Pulse Biosciences Quality Policy and Quality System
Qualification
Required
BS degree in Engineering, Science or a related field
5 years of progressive quality engineering experience with Class II/III products in the medical device industry
Must have extensive work experience with FDA QSR (21 CFR Part 820 & Part 11) and ISO 13485/MDR requirements are required
Must have extensive knowledge and experience in Risk Assessment (ISO 14971) practices and implementation
Knowledge and experience in ISO 10993 standard series (Biocompatibility), AAMI/ISO 11135 & 11137 (EO & Irradiation sterilization), ISO 11607 & ASTM D4169 (Sterile Packaging & Performance Testing)
Hands-on experience with medical devices from development through commercialization is highly desirable
Mastered the use of quality disciplines, tools, and methodologies
Proficient knowledge and skill in Microsoft Office Suite applications
Excellent oral written communication skills and critical thinking skills
Ability to work conscientiously and with minimal direction, using good judgement, taking initiative to accomplish short and long-range projects, and recommend actions with minimal direction
Ability to work as a team member, multi-task and be very flexible to adapt to the ever-changing work priorities and requirements of a dynamic, fast-growing company
Ability to travel up to 10% of the time. Overnight and/or international travel may be required
Ability to lift 10-15 pounds
Preferred
Cardiovascular device experience is strongly preferred
Experience working in a start-up environment a plus
Benefits
A variety of health insurance plans and supplemental insurance options
401k retirement savings plan
Stock options awards
Employee Stock Purchase Plan (ESPP)
Paid time off
Paid holidays
Flexible work schedule
Wellness program, including onsite gym and mindfulness classes
Company
Pulse Biosciences, Inc.
Pulse Biosciences is the inventor and sole proprietor of Nanosecond Pulsed Field Ablation™ (nsPFA™) technology.
51-200 employees
H1B Sponsorship
Pulse Biosciences, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
2023 (1)
2022 (2)
2021 (1)
2020 (3)
Funding
Current Stage
Public CompanyTotal Funding
$233.34MKey Investors
Virginia Catalyst
2023-05-01Post Ipo Equity· $65M
2021-07-01Post Ipo Equity· $50M
2020-06-16Post Ipo Equity· $30M
Leadership Team
D
Darrin Uecker
Chief Technology Officer
Kevin Danahy
Chief Commercial Officer (CCO)
Recent News
2025-12-18
Company data provided by crunchbase