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:

· 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