{"id":2882508,"url":"https://alion.io/job/pulse-biosciences-principal-quality-engineer","title":"Principal Quality Engineer","company":{"id":686684,"name":"Pulse Biosciences","domain":"pulsebiosciences.com","url":"https://alion.io/company/pulsebiosciences","size_band":"51-200","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"lead","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Hayward, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":145000,"max":180000,"currency":"USD","period":"year","gross":null,"usd_annual":180000},"salary_estimate":null,"experience_years_min":10,"visa_sponsorship":false,"relocation_package":false,"has_equity":true,"technologies":[{"name":"21 CFR Part 820","optional":false},{"name":"CAPA","optional":false},{"name":"Design Controls","optional":false},{"name":"ISO 10993","optional":false},{"name":"ISO 13485","optional":false},{"name":"ISO 14971","optional":false},{"name":"Microsoft Office","optional":false},{"name":"Sterilization Validation","optional":false},{"name":"Verification & Validation","optional":false}],"status":"live","first_seen_at":"2026-10-19T22:22:21Z","employer_posted_date":"2026-10-20","last_verified_at":"2026-10-26T13:13:01Z","board_verified":true,"closed_at":null,"days_open":6,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":6},"description":"Pulse Biosciences (Nasdaq: PLSE): Join the Future of Bioelectric Medicine\nPulse Biosciences is a novel bioelectric medicine company committed to health innovation that has the potential to improve the quality of life for patients. The Company’s proprietary CellFX® nsPFA™ (nanosecond Pulsed Field Ablation) technology delivers nanosecond pulses of electrical energy to non-thermally ablate cells while sparing adjacent noncellular tissue.\nThe Company is actively pursuing the development of its CellFX nsPFA technology for use in the surgical treatment of atrial fibrillation and percutaneously in a select few other markets where it could have a profound positive impact on healthcare for both patients and providers. Visit pulsebiosciences.com to learn more.\nWhy Join Us?\nAt Pulse Biosciences, we are driven by purpose and innovation.\nOur Mission: To build a viable Company that designs, produces, and commercializes nano-pulse technology to improve and extend the lives of patients. To solve the needs of patients, physicians, and healthcare providers with high quality and high reliability products and services, developed in accordance with rigorous scientific, engineering, and clinical standards. We exist to make a positive difference in the lives of patients, physicians, healthcare providers, shareholders and our Pulse Biosciences team members. \nOur Culture: A community of creative, forward-thinking individuals tackling challenges with ingenuity and collaboration.\nOur Commitment: Hiring the best and brightest minds to advance our world-class organization.\nWhat You Will Experience: \nCulture and Purpose - Purposeful and rewarding work collaborating with bright and curious minds brings us together!\nInnovative Environment - An environment that fosters innovation to take products from concept to human use quickly!\nGrowth Opportunities - Learning culture focusing on professional and personal growth and development that you can only get in a startup-like environment!\nComprehensive Benefits - A variety of health insurance plans and supplemental insurance options, and 401k retirement savings plan.\n Ownership and Rewards - Stock options awards and Employee Stock Purchase Plan (ESPP) to share in our success.\nWork-Life Balance - Enjoy paid time off, paid holidays, flexible work schedule and wellness program, including onsite gym and mindfulness classes.\nDiversity & Inclusion - A commitment to providing a respectful work environment to our diverse workforce. \nAbout the Role\nThe Principal Quality Engineer will participate in the implementation and maintenance of QSR (21 CFR 820) and ISO 13485 quality systems and qualification activities of CellFX System, surgical disposable and reusable medical devices in support of the Company’s research and development, manufacturing, regulatory, and clinical affairs efforts. In addition, this individual will support the development and implementation of quality systems and compliance activities.\nTo Make an Impact, You Will:\nProvide expertise and guidance to product development and manufacturing teams in the areas of design assurance, design controls and compliance.\nDevelop, establish, and maintain quality engineering methodologies, systems and practices that meet Pulse Biosciences’ customer and regulatory requirements.\nLead the risk management process in establishing risk management plan, conducting risk evaluation and analysis, and creating risk management report.\nLead the process in establishing product traceability matrices, conducting requirement trace verification and analysis, and creating trace matrix reports.\nManage all aspects of biocompatibility testing and sterilization including creating of test protocols and executing of testing.\nProactively investigate, identify, and implement best-in-class quality engineering practices.\nIdentify 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.\nDevelop and validate measurement methods, monitor design control standards, facilitate, and perform statistical analysis, and participate in MRB as appropriate.\nLead the review of process and product quality performance, working in concert with various departments.\nAssist with development protocols for design verification and validation in conjunction with R&D\nDesign and implement methods and procedures for inspecting, testing, and evaluating components, sub-assemblies, and final assemblies.\nSupport management review activities, regulatory audits including Notified Body audit (MDSAP) and assist with preparation of regulatory submissions.\nCarry out responsibilities in accordance with the organization’s policies and applicable laws.\nSupport the Pulse Biosciences Quality Policy and Quality System. Other duties as assigned.\nTo Excel, You Will Bring:\nBachelor’s degree in Engineering, Science, related technical/life science field or equivalent experience.\n10+ years working as a Quality Engineer within a Class III/II medical device industry. Cardiovascular device experience is preferred.\nMust have extensive work experience with FDA QSR (21 CFR Part 820 & Part 11) and ISO 13485/MDR requirements are required.\nMust have extensive knowledge and experience in Risk Assessment (ISO 14971) practices and implementation.\nKnowledge and experience in ISO 10993 standard series (Biocompatibility), AAMI/ISO 11135 & 11137 (EO & Irradiation sterilization), ISO 11607 & ASTM D4169 (Sterile Packaging & Performance Testing).\nHands-on experience with catheter-based devices from development through commercialization.\nMastered the use of quality disciplines, tools, and methodologies.\nMust also have working knowledge and experience in the following areas:Design Control\nDesign & Process Validation\nRisk Management\nTraceability Matrix\nBiocompatibility\nSterilization Validation\nPackaging Validation\nStatistical Analysis\nQuality System Compliance\nComplaint handling\nCAPA management\n\nProficient knowledge and skill in Microsoft Office Suite applications.\nExcellent oral written communication skills and critical thinking skills.\nAbility to work conscientiously and with minimal direction, using good judgment, taking initiative to accomplish short and long-range projects, and recommend actions with minimal direction.\nAbility 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.\nAbility to travel up to 10% of the time. Overnight and/or international travel may be required.\nAbility to lift 10-15 pounds.\nPay Range:\nCompensation is determined based on a wide range of factors including location, job-related skills, experience, education, and training. It is not typical for an individual to be hired at or near the top of the range for their role. This pay range is specific to Northern California location. Base salary range: $145k-$180k. This position is located onsite in Hayward, CA and candidates must reside in the San Francisco Bay Area. No relocation offered.\nReady to Shape the Future of Healthcare?\nApply today to join Pulse Biosciences and help us redefine the boundaries of medicine with bioelectric innovation. To learn more about us, visit our website at www.pulsebiosciences.com.\nWe provide equal employment opportunities (EEO) to all persons regardless of race, age, color, gender, sexual orientation, national origin, physical or mental disability, religion, or any other characteristic protected by federal, state or local law. We will make reasonable accommodations for qualified individuals with disabilities.\nPRINCIPALS ONLY; UNSOLICITED CANDIDATE SUBMISSIONS FROM RECRUITERS OR THIRD-PARTY AGENCIES WILL BE CONSIDERED FREE REFERRALS.","description_format":"text","description_chars":7765,"description_truncated":false,"requirements":{"experience_years_min":10,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["401k plan","Flexible schedule","Growth opportunities","Health insurance","Retirement plans","Stock options"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":true,"industries":["Biotechnology","Surgical Instruments & Devices"],"lifecycle":[{"event":"open","at":"2026-10-19T23:12:18Z"}],"visa":[],"liveness":{"score":90,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.903,"p_room":1,"age_days":6,"expected_fill_days":30,"reasons":["conf:1","velocity","win:early"],"computed_at":"2026-10-26T05:57:25Z"},"pay":{"stated_usd_annual":180000,"is_top_pay":true},"html_url":"https://alion.io/job/pulse-biosciences-principal-quality-engineer","json_url":"https://alion.io/job/pulse-biosciences-principal-quality-engineer.json","meta":{"generated_at":"2026-10-26T16:25:14Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":21871,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-27T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":686684},"rest":"https://alion.io/mcp/rest/get_company?id=686684"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fpulse-biosciences-principal-quality-engineer"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fpulse-biosciences-principal-quality-engineer"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fpulse-biosciences-principal-quality-engineer"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/pulse-biosciences-principal-quality-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fpulse-biosciences-principal-quality-engineer"}]}