Design Transfer SME
Job in
Buffalo, Erie County, New York, 14266, USA
Listed on 2026-08-25
Listing for:
Creative Solutions Services, LLC
Full Time
position Listed on 2026-08-25
Job specializations:
-
Manufacturing / Production
Manufacturing Engineer, Medical Device Industry, Quality Engineering, Product Engineer -
Engineering
Manufacturing Engineer, Medical Device Industry, Quality Engineering, Product Engineer
Job Description & How to Apply Below
Summary:
We are seeking a senior-level Design Transfer SME / Technical Lead to lead the transition of complex medical devices from R&D to Pilot Manufacturing to Production.
The ideal candidate is a strong technical decision-maker with experience bringing complex electromechanical medical devices from engineering through commercialization.
Roles & Responsibilities- Diagnostic Imaging / Capital Equipment.
- Complex Electromechanical Medical Devices.
- Software-Enabled Medical Devices.
- AI-Driven Medical Devices.
- Systems Engineering / Product Commercialization.
- Advanced Engineering Degree.
- Lead Design Transfer & Design Control activities.
- Bridge R&D, Systems, Mechanical, Manufacturing & Quality teams.
- Develop and optimize manufacturing processes and assembly methods.
- Build and troubleshoot pilot units.
- Identify design, tooling and assembly risks before production scale-up.
- Drive manufacturing readiness from prototype to pilot to high-volume production.
- Develop DMRs, work instructions and manufacturing documentation.
- Resolve complex manufacturing and assembly issues.
- Serve as the technical decision-maker and engineering liaison.
- 12+ years Medical Device experience.
- Design Control & Design Transfer expertise.
- Proven leadership of complex electromechanical medical device transfers.
- Pilot Manufacturing & Manufacturing Readiness.
- Product Development & Manufacturing Engineering.
- Manufacturing Process Development & Optimization.
- DMR, Work Instructions & Assembly Procedures.
- Mechanical & Systems-Level Assembly Troubleshooting.
- FDA / ISO 13485 / Design Control knowledge.
- Strong R&D, Manufacturing & Quality leadership.
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