About this role

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

· 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