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Manufacturing Engineer

BiotalentSan Jose, CAApril 23rd, 2026
Manufacturing Engineer | Medical Device (AI / Imaging Platform)About the RoleJoin a fast-growing medical device company building an AI-driven platform focused on improving access to early cancer detection. This role will lead manufacturing development and production scale-up for a complex electromechanical system, working cross-functionally with engineering and suppliers.What You’ll DoDrive DFx (Design for Manufacturing/Assembly) to improve cost and scalabilityDevelop and implement manufacturing processes, workflows, and production layoutsSupport production ramp with hands-on troubleshooting and process improvementsDesign and validate test fixtures for engineering and manufacturing useOwn manufacturing documentation (DMR/DHR, work instructions, test methods)Optimize BOMs, workflows, and assembly processes for efficiencyLead failure analysis and support CAPA activitiesPartner with suppliers to qualify components and improve qualityTrack and report manufacturing KPIsRequirementsBachelor’s in Mechanical, Manufacturing, Industrial, or related engineering field5+ years in manufacturing (medical device or regulated industry preferred)Experience with electromechanical assembliesStrong knowledge of manufacturing processes (machining, molding, welding, etc.)CAD experience (SolidWorks or similar)Hands-on problem solver with strong cross-functional communication skillsNice to HaveNPI experience in medical devicesISO 13485 or regulated environment experienceExperience with PCBA test fixturesStatistical process validation experience