About this opportunity
Capstan Medical, Inc. lists this Senior Manufacturing Engineer - Implant opportunity in santa cruz, California. Review the employer’s description below for duties, qualifications and application requirements.
Job description
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:
Capstan Medical is seeking a Senior Manufacturing Engineer to lead manufacturing development and productization of new sizes of the Capstan Mitral Valve implant. This role is part of the Implant Manufacturing team and will partner closely with R&D to translate new implant designs into robust, validated, and scalable production processes, serving as the manufacturing lead from early design through design transfer and launch.
Responsibilities & Skills:
Key Responsibilities:
Own manufacturing development for new implant sizes, from early design input through design transfer and production release
Scale existing implant processes, tooling, and documentation across the size matrix, identifying size‑dependent risks early
Provide DFM input to R&D during design and design reviews, and influence designs for manufacturability, yield, and cost
Design, qualify, and release size‑specific fixtures, mandrels, and tooling for forming, assembly, loading, and inspection
Plan and execute engineering, verification, and clinical builds for new sizes in partnership with R&D, Quality, and Operations
Lead process characterization and validation (IQ/OQ/PQ, TMV) and apply DOE and statistical methods to set robust process windows
Author and maintain PFMEAs, process flows, MPIs, DHRs, and inspection procedures for new product introductions
Engage suppliers early on new‑size components, drive first article inspections, and ensure component quality and capacity
Train technicians/operators on new processes and support build readiness through launch
Address process and component NCRs and drive root cause and corrective actions during development and early production
Capture lessons learned and build scalable, platform‑based approaches that accelerate future size and next‑gen introductions
Skills:
Excellent communication and documentation skills, including technical protocols and reports
CAD and mechanical design skills, with experience designing fixtures and tooling
Working knowledge of process validation, DOE, SPC, and PFMEA
Ability to manage multiple parallel builds and timelines in a fast‑paced, early‑stage environment
Excellent technical and logistical problem‑solving skills
Requirements:
Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Biomedical Engineering, or related field
Minimum 5 years of relevant experience in a medical device manufacturing environment, including new product development and design transfer
Hands‑on experience taking a product from development builds through validation and into production
Familiarity with ISO 13485, 21 CFR 820, and ISO 14971
Preferred: experience with Class III implants or structural heart devices, nitinol processing, or tissue/textile‑based implant assembly
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Worksite address
santa cruz, CA, 95061, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.