{"id":922611,"url":"https://alion.io/job/pulsebiosciences-sr-process-development-engineer-catheter-engineering","title":"Sr. Process Development Engineer, Catheter Engineering","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":"senior","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":130000,"max":155000,"currency":"USD","period":"year","gross":null,"usd_annual":155000},"salary_estimate":null,"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":true,"technologies":[{"name":"SolidWorks","optional":false}],"status":"live","first_seen_at":"2026-09-14T19:07:04Z","employer_posted_date":"2026-10-07","last_verified_at":"2026-10-13T04:55:53Z","board_verified":true,"closed_at":null,"days_open":28,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":28},"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 Sr. Process Development Engineer will be responsible to bridge early-stage device development and commercial-grade manufacturing. This individual will take first-in-human catheter devices and refine them into robust, manufacturable products ready for commercial launch. The ideal candidate will bring deep catheter engineering expertise, a manufacturing mindset, and a proven track record of successful medical device design transfer.\nTo Make an Impact, You Will:\nLead process development activities to transition early-stage catheter devices from first-in-human configurations to commercially viable, scalable products.\nPerform DFM/DFA analyses and tolerance stack-up studies (worst-case and statistical) to eliminate producibility risks, define critical dimensions, and establish component acceptance criteria.\nDevelop and maintain detailed component specifications, drawing requirements, and incoming inspection criteria, including AQL sampling plans, in alignment with device performance requirements and supplier capabilities.\nCharacterize and optimize catheter manufacturing processes including extrusion, braiding, tip forming, thermal bonding, adhesive joining, and laser cutting to achieve robust, repeatable outcomes.\nDevelop and optimize electrical assembly processes for catheter-integrated components, including fine-gauge wire termination, surface mount component placement, and high- and low-voltage cable assembly fabrication in compliance with applicable industry workmanship standards.\nPartner with Manufacturing Engineering on process validation (IQ, OQ, PQ) and process FMEAs; contribute to protocols, risk documentation, and control definitions to ensure regulatory compliance.\nCollaborate with Manufacturing Engineering to establish SPC methods, capability studies (Cp, Cpk), yield targets, and build monitoring frameworks that support production stability and COGS objectives.\nDevelop inspection gauges and conduct MSA/gauge R&R studies to validate measurement system capability.\nEvaluate and qualify raw materials, adhesives, and components; assess material compatibility, processability, and biocompatibility implications.\nInitiate and manage engineering change orders (ECOs) to implement process improvements while maintaining design history file integrity.\nEnsure components and processes under development are compatible with sterilization methods (EO, gamma, e-beam) and packaging requirements in collaboration with quality and regulatory teams.\nApply lean manufacturing principles to reduce waste and improve cycle times in preparation for commercial scale-up.\nPartner with suppliers and contract manufacturers to evaluate process capabilities, establish manufacturing requirements, and drive continuous improvement.\nCreate and maintain manufacturing work instructions, assembly procedures, and process travelers to support design transfer and production readiness.\nCollaborate cross-functionally with R&D, quality, regulatory, and manufacturing teams to align process activities with design controls and program timelines.\nMentor junior engineers and technicians on process-related problem solving and root cause analysis.\nTo Excel, You Will Bring:\nBachelor’s degree in Mechanical Engineering, Biomedical Engineering, Materials Science, Manufacturing Engineering, or a related field; Master's degree preferred.\nMinimum 5 years of medical device process development or manufacturing engineering experience, with at least 3 years focused on catheter-based devices, including demonstrated experience taking a device from early-stage development to commercial manufacturing.\nHands-on experience with catheter manufacturing processes including extrusion, braiding, thermal bonding, tip forming, adhesive assembly, and laser processing.\nProficiency in tolerance stack-up analysis (worst-case and statistical) and working knowledge of statistical methods (Cp/Cpk, SPC, gauge R&R); DOE experience a plus.\nExperience supporting process validation (IQ, OQ, PQ) in a regulated medical device environment.\nFamiliarity with FDA QSR (21 CFR Part 820), ISO 13485, and ISO 14971 risk management requirements.\nExperience developing component specifications and working with suppliers to establish and verify manufacturing capabilities.\nProficient in CAD tools (SolidWorks preferred) and GD&T per ASME Y14.5; familiarity with statistical software (Minitab or equivalent) preferred.\nWorking knowledge of catheter materials including thermoplastic polymers (PEBAX, nylon, polyurethane, PTFE), metallic components (nitinol, stainless steel, platinum-iridium), and adhesive systems.\nStrong analytical and problem-solving skills; experience with root cause analysis tools including FMEA, fishbone diagrams, 8D, and 5 Whys.\nCleanroom experience preferred (ISO Class 7 or 8); strong project management skills with ability to manage multiple concurrent programs.\nStrong written and verbal communication skills; able to work independently and collaboratively in a fast-paced, cross-functional environment.\nAbility to work conscientiously and with minimal direction, using good judgement and taking initiative to accomplish assigned tasks.\nAbility to work as a team member, multi-task, and adapt to the changing priorities of a dynamic, fast-growing company.\nOccasional travel may be required up to 15% of the time, primarily for supplier qualification, contract manufacturing, and design transfer activities.\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: $130k-$155k. 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":9093,"description_truncated":false,"requirements":{"experience_years_min":5,"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":["Cardiovascular Devices","Biotechnology","Surgical Instruments & Devices"],"lifecycle":[{"event":"open","at":"2026-09-15T02:25:34Z"}],"visa":[],"liveness":{"score":56,"band":"ok","label":"Likely open","p_open":1,"p_active":0.749,"p_room":0.75,"age_days":28,"expected_fill_days":37,"reasons":["conf:0","win:late"],"computed_at":"2026-10-13T05:45:00Z"},"pay":{"stated_usd_annual":155000,"is_top_pay":true},"html_url":"https://alion.io/job/pulsebiosciences-sr-process-development-engineer-catheter-engineering","json_url":"https://alion.io/job/pulsebiosciences-sr-process-development-engineer-catheter-engineering.json","meta":{"generated_at":"2026-10-13T08:08:41Z","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":11991,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-14T00:00:00Z"}},"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%2Fpulsebiosciences-sr-process-development-engineer-catheter-engineering"},{"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%2Fpulsebiosciences-sr-process-development-engineer-catheter-engineering"},{"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%2Fpulsebiosciences-sr-process-development-engineer-catheter-engineering"},{"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/pulsebiosciences-sr-process-development-engineer-catheter-engineering\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fpulsebiosciences-sr-process-development-engineer-catheter-engineering"}]}