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Manufacturing Engineer

BioTalent
Sunnyvale, CA Full Time
POSTED ON 4/21/2026
AVAILABLE BEFORE 5/20/2026

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

Salary : $100,000 - $140,000

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