Quality Engineer, Heart Valve Product Quality

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.

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.

• 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.

• Strong understanding of medical device quality systems, design controls, risk management, production/process controls, acceptance activities, change control, NCR, MRB, and CAPA.
• Working knowledge of structural heart valve/cardiovascular implant standards and expectations; ISO 5840 experience preferred.
• Experience with sterile medical device processes, with 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,…