Manufacturing Engineer II - Implant

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. Responsibilities & Skills: Key Responsibilities: · Support manufacturing development of new implant sizes, from engineering builds through design transfer and production release · Adapt existing implant processes, work instructions, and tooling to new sizes, flagging size-dependent issues to the team · Provide DFM/DFA feedback to R&D during design reviews and development builds · Design, build, and qualify size-specific fixtures and tooling for assembly, loading, and inspection · Plan and execute engineering, verification, and clinical builds with R&D, Quality, and Operations · Draft and execute process characterization and validation protocols (IQ/OQ/PQ, TMV), using DOE and statistical tools to analyze results · Draft and revise MPIs, DHRs, PFMEAs, inspection procedures, and engineering change orders for new product introductions · Support supplier onboarding for new-size components, including first article inspections · Train technicians/operators on new processes and support builds on the floor · Investigate process and component NCRs and support root cause and corrective actions Skills: · Process Development - Ability to develop, document, and refine manufacturing processes for medical devices · Validation - Experience writing and executing IQ/OQ/PQ protocols · CAD & Fixture Design - Proficient in SolidWorks or similar for fixture/tooling design · Root Cause Analysis - Experience with 5 Whys, Fishbone Diagrams, and other RCA methods · Assembly Techniques - Familiarity with precision assembly, especially under a microscope, and biocompatible material handling · Document Control - Ability to work within a QMS and manage DCNs · Excellent communication, documentation, and problem-solving skills, with the ability to manage multiple priorities Requirements: Requirements: · Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Biomedical Engineering, or related field · Minimum 2 years of relevant experience in a medical device or regulated manufacturing environment, with exposure to new product development or design transfer · Working knowledge of GMP, 21 CFR 820, and ISO 13485 · Experience with validation (IQ/OQ/PQ), risk management (FMEA), and statistical tools (Minitab, JMP) · Preferred: experience with Class III implants or heart valves, cleanroom micro-assembly, or biological material handling