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: 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