Manufacturing EngineerPosition OverviewWe 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 ResponsibilitiesDesign, 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.

QualificationsBachelors 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.

BenefitsHealth insuranceRetirement benefitsPaid time off/vacation