Capstan Medical, Inc.
Quality Engineer, Heart Valve Product Quality
Santa Cruz, California
Sponsorship not specifiedDetected 20 days ago
Data AnalysisRoboticsFDA RegulatoryMedical DevicesCommunicationProblem SolvingRegulatory Affairs
About the role
- 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.
Requirements
- Experience establishing manufacturing acceptance activities, inspection/test methods, sampling plans, acceptance criteria, and quality records in a regulated production environment.
- Experience working in cleanroom or controlled manufacturing environments
Nice to have
- advanced degree or CQE/CQA/ASQ certification is a plus.
- experience with Class III, implantable, cardiovascular, structural heart, tissue-based, or sterile devices is strongly preferred.
- liquid chemical sterilization experience is strongly preferred.
- Bachelor's degree in Engineering, Life Sciences, Microbiology, or a related technical field
Skills
- Working knowledge of structural heart valve/cardiovascular implant standards and expectations
- ISO 5840 experience preferred.
- Strong problem-solving, technical judgment, data analysis, documentation, and risk-based decision-making skills.
- Working knowledge of structural heart valve/cardiovascular implant standards and expectations; ISO 5840 experience preferred.
Benefits
- We offer a fun, fast-paced, collaborative environment where you will be working on transformational technologies in the cardiac healthcare space that can make a meaningful impact for patients
- We offer outstanding benefits with medical, dental, and vision covered at 100% for you and your family, as well as flex time off
Equal opportunity
- We are an equal opportunity employer.
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