Quality Engineer, Heart Valve Product Quality
About The Position
At Capstan Medical, we’re building one of the most exciting and innovative companies in medtech—developing a first-of-its-kind robotic platform for minimally invasive heart valve treatment. Our team combines surgical robotics, catheter-based delivery, and next-generation implants to transform complex procedures into safer, lower-stress solutions for patients and clinicians alike. As a highly collaborative, hands-on team, we move fast, wear multiple hats, and believe the best ideas can come from anyone. Based in Santa Cruz, our unique workspace blends cutting-edge Bay Area innovation with a lifestyle-driven environment near trails, beaches, and open space—creating the perfect place to do meaningful, career-defining work. Role Summary: The Quality Engineer supports Capstan Medical's mitral and/or tricuspid structural heart valve product line from development through manufacturing readiness and production. This role partners with R&D, Operations/Manufacturing, Regulatory Affairs, and Quality to ensure design controls, risk management, sterilization, microbiology test methods, acceptance activities, and release processes meet company and regulatory expectations.
Requirements
- Bachelor's degree in Engineering, Life Sciences, Microbiology, or a related technical field; advanced degree or CQE/CQA/ASQ certification is a plus.
- 5+ years of quality engineering experience in medical devices; experience with Class III, implantable, cardiovascular, structural heart, tissue-based, or sterile devices is strongly preferred.
- Experience supporting design controls, risk management, design transfer, verification/validation, DHF/DMR documentation, and product/process changes.
- Experience establishing manufacturing acceptance activities, inspection/test methods, sampling plans, acceptance criteria, and quality records in a regulated production environment.
- Experience supporting sterilization validation, routine control, microbiology testing, and product release for sterile medical devices; liquid chemical sterilization experience is strongly preferred.
- Familiarity with relevant regulations and standards, including FDA 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, ISO 5840, ISO 14160, ISO 22442, ISO 11135, and applicable sterilization, packaging, biocompatibility, and microbiology test standards.
- Experience working in cleanroom or controlled manufacturing environments; ability to work onsite and cross-functionally with R&D and Operations teams as needed.
Nice To Haves
- Advanced degree or CQE/CQA/ASQ certification is a plus.
- ISO 5840 experience preferred.
- Strong preference for liquid chemical sterilization and animal tissue-containing products.
- Working knowledge of microbiology and sterility assurance test methods, including bioburden, sterility, endotoxin/BET-LAL, microbial identification, and related test method controls.
- Ability to translate design, manufacturing, sterilization, and risk requirements into practical inspection/test methods, acceptance criteria, and release requirements.
- Strong problem-solving, technical judgment, data analysis, documentation, and risk-based decision-making skills.
- Effective cross-functional communication with R&D, Operations, Manufacturing Engineering, Regulatory Affairs, technicians, auditors, suppliers, labs, and sterilization partners.
Responsibilities
- Serve as the Quality Engineering representative for assigned structural heart valve products, supporting design controls, risk management, design verification/validation, design transfer, DHF/DMR content, and product/process changes.
- Apply knowledge of structural heart implant expectations, including the ISO 5840 series, to support product requirements, verification/validation strategies, and objective evidence.
- Support liquid chemical sterilization activities for products that may contain animal-derived tissue, including validation, routine monitoring, deviations, requalification, and release support; maintain working knowledge of ISO 14160, ISO 22442, ISO 11135, and other relevant sterilization standards.
- Support sterilization-related microbiology test methods and data review, including bioburden, sterility, bacterial endotoxin/BET-LAL, microbial identification, method suitability, excursions, and trending; provide trained backup support to the in-house microbiologist for defined routine activities as needed.
- Assist Operations and Manufacturing Engineering in establishing acceptance activities, including incoming, in-process, and final inspection/test requirements, sampling plans, acceptance criteria, inspection methods, test method validation needs, fixtures, and quality records.
- Support cleanroom and controlled manufacturing operations, including issue triage, process validation/qualification review, line readiness, DHR review, finished goods release, and lot/batch disposition.
- Lead or support NCR, MRB, CAPA, audit, and continuous improvement activities, including root cause analysis, risk-based disposition, effectiveness verification, and quality data trending.
- Create, review, and improve SOPs, work instructions, forms, templates, and quality records related to product quality, sterilization, microbiology testing, acceptance activities, DHR review, and manufacturing quality processes.
Benefits
- Medical, dental, and vision covered at 100% for you and your family
- Flex time off
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
