Manufacturing Engineer

Manufacturing Engineer at BioTalent Manufacturing Engineer at BioTalent in Los Altos, California Posted in 2 days ago.

Type:

full-time

Job Description:

Manufacturing Engineer | Medical Device (AI / Imaging Platform) About the Role Join 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 Do Drive DFx (Design for Manufacturing/Assembly) to improve cost and scalability Develop and implement manufacturing processes, workflows, and production layouts Support production ramp with hands-on troubleshooting and process improvements Design and validate test fixtures for engineering and manufacturing use Own manufacturing documentation (DMR/DHR, work instructions, test methods) Optimize BOMs, workflows, and assembly processes for efficiency Lead failure analysis and support CAPA activities Partner with suppliers to qualify components and improve quality Track and report manufacturing KPIs Requirements Bachelor's in Mechanical, Manufacturing, Industrial, or related engineering field 5+ years in manufacturing (medical device or regulated industry preferred) Experience with electromechanical assemblies Strong knowledge of manufacturing processes (machining, molding, welding, etc.) CAD experience (SolidWorks or similar) Hands-on problem solver with strong cross-functional communication skills Nice to Have NPI experience in medical devices ISO 13485 or regulated environment experience Experience with PCBA test fixtures Statistical process validation experience