Design Transfer SME
Katalyst HealthCares & Life Sciences
Job-ID32880764Reference26-01500Remote50% RemoteSummary:We are seeking a senior-level Design Transfer SME / Technical Lead to lead the transition of complex medical devices from R&D Pilot Manufacturing 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 pilot 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.Requirements: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.
Vacancy posted 2 days ago
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