Senior Manufacturing Engineer - Implant

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.

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

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.