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

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.