Senior Manufacturing Engineer - Implant
Capstan Medical · Santa Cruz, California, United States · onsite
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:
- 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