Manufacturing Engineer

Manufacturing Engineer

We are seeking a Manufacturing Engineer to support design-for-manufacturability and production of high-quality medical devices, with a focus on orthopedic implants. The role will apply engineering principles to develop, optimize and document manufacturing processes for precision components and implantable devices. The successful candidate will partner with R&D, quality and production teams to improve yield, reduce cycle times and ensure compliance with medical device regulations.

Key Responsibilities

• Design, develop and implement manufacturing processes for orthopedic implants and related medical devices, emphasizing precision, repeatability and regulatory compliance.
• Translate product designs into robust manufacturing methods including CNC machining, grinding, EDM and finishing operations.
• Perform process development and continuous improvement activities using root-cause analysis, FMEA, SPC and lean manufacturing principles to improve yield, quality and throughput.
• Create and maintain process documentation: work instructions, process flow diagrams, control plans, and validation protocols required for medical device manufacturing.
• Collaborate with design engineers on design-for-manufacturability (DFM) and design-for-testability (DFT) to optimize part geometry, tolerances and material selection.
• Develop CNC programs and tooling specifications; support machine setup, first article builds and productionization.
• Conduct tolerance analysis, machine dynamics assessment and tribology evaluations to ensure long-term performance and wear characteristics of implant surfaces.
• Use advanced CAD for process planning, fixturing, and tolerance stack-ups; support engineering drawings and BOMs.
• Apply computational tools such as CFD or other simulation methods where applicable to optimize coolant delivery, debris evacuation and process thermal control.
• Lead cross-functional problem-solving for nonconforming product and supplier issues, and support corrective and preventive actions (CAPA).
• Provide training and technical support to manufacturing operators and technicians to ensure consistent adherence to processes and quality standards.
• Participate in design and execution of process validations, equipment qualification, and production scale-up activities in compliance with ISO 13485 and FDA requirements.

Qualifications

• Bachelors degree in Mechanical Engineering, Manufacturing Engineering or related engineering discipline; Masters degree preferred.
• 3+ years of manufacturing engineering experience in medical device production, ideally with orthopedic implants or precision implantable components.
• Demonstrated experience with CNC programming, tooling, machine setup and process development for metal components.
• Strong knowledge of manufacturing principles including DFM, lean, SPC, FMEA and GD&T.
• Experience with tribology and machine dynamics related to component wear, surface finishes and bearing interfaces.
• Hands-on proficiency with advanced CAD (SolidWorks, CATIA or NX) for modeling, tooling design and tolerance analysis.
• Familiarity with computational tools such as CFD or machining simulations to optimize process conditions is a plus.
• Working knowledge of medical device regulations and quality systems (ISO 13485, FDA 21 CFR 820) and experience supporting process validation and documentation.
• Excellent troubleshooting, analytical and problem-solving skills with experience in root-cause analysis and corrective action implementation.
• Strong communication and teamwork skills; ability to lead cross-functional projects and train production staff.
• Preferred: experience with orthopedic implants, surface treatments, finishing processes and supplier management.

Benefits

• Health insurance
• Retirement benefits
• Paid time off/vacation