Design Transfer SME / Technical Lead – Medical Devices

Design Transfer SME / Technical Lead Medical Devices About The Company Stark Pharma Solutions Inc. is a global consulting and staffing partner established in 2014, serving the Pharmaceutical, Medical Device, Biotech, and IT industries across the USA, Canada, and India. We provide specialized consulting and staffing solutions across Quality & Validation, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Project Management, and IT, with a focus on delivering tailored solutions that drive growth, operational excellence, and long-term client success. Job Overview We are seeking a senior-level Design Transfer SME / Technical Lead to lead the transition of complex medical devices from R&D through Pilot Manufacturing to Production. This is a high-level SME / Technical Lead role, not a traditional hands-on manufacturing engineer position. The ideal candidate is a strong technical decision-maker with experience bringing complex electromechanical medical devices from engineering through commercialization. Key Responsibilities Lead Design Transfer and Design Control activitiesBridge R&D, Systems, Mechanical, Manufacturing, and Quality teamsDevelop and optimize manufacturing processes and assembly methodsBuild and troubleshoot pilot unitsIdentify design, tooling, and assembly risks before production scale-upDrive manufacturing readiness from prototype through pilot to high-volume productionDevelop DMRs, work instructions, and manufacturing documentationResolve complex manufacturing and assembly issuesServe as the technical decision-maker and engineering liaison Required Qualifications 12+ years of Medical Device experienceDesign Control and Design Transfer expertiseProven leadership of complex electromechanical medical device transfersPilot Manufacturing and Manufacturing Readiness experienceProduct Development and Manufacturing Engineering backgroundManufacturing Process Development and Optimization experienceExperience with DMR, Work Instructions, and Assembly ProceduresMechanical and systems-level assembly troubleshooting skillsFDA / ISO 13485 / Design Control knowledgeStrong R&D, Manufacturing, and Quality leadership experience GOOD TO HAVE Diagnostic Imaging / Capital Equipment experienceComplex Electromechanical Medical Devices backgroundSoftware-Enabled Medical Devices experienceAI-Driven Medical Devices exposureSystems Engineering / Product Commercialization experienceAdvanced Engineering Degree How To Apply Apply Now: Submit your updated resume to Stark Pharma Solutions Inc. for consideration. Stark Pharma is an Equal Opportunity Employer and welcomes qualified candidates from diverse backgrounds.