Component Engineer

3 days ago


sunnyvale, United States TotalMed, Inc. Full time

Job Title: Component Engineer

Industry/Segment: Biomedical Device Manufacturing/Engineering

Location: Sunnyvale, CA 94086

Schedule: Monday – Friday 8:00am-5:00pm

Pay: $53/hr ($110k/yr) + Benefits: Med/Den/Vis


Job Description:

  • This role will focus on manufacturing of mechanical parts and assemblies of part manufactured using all major manufacturing methods including CNC, sheet metal, plastic injection molding, extrusions and electronics
  • Drive projects to continually improve supply base business and manufacturing process performance to meet Intuitive Surgical’s requirements for supplier excellence using a collection of best practices in project management, Six Sigma, Lean, SPC and negotiation
  • Work with suppliers to execute cost reductions, capacity improvements, and risk mitigation
  • Examples include supplier changes, manufacturing process changes, PPQPs, production optimization, facility changes, new equipment qualification, and new line validations
  • Improve quality and ensure continuous improvement with suppliers by utilizing structure problems solving processes such as 8D, root cause analysis, corrective actions, etc.
  • Manage quality discrepancies through the execution of quality notifications & manage the planning and execution of supplier change management projects
  • Collaborate with suppliers and internal stakeholders to determine deliverables and define timelines
  • Complete project deliverables including: Supplier pFMEA, Process Validations (IQ/OQ/PQ), Inspection Reports, Gage R&R, and Process Capability Analysis
  • Effectively prioritize & advance multiple concurrent projects and tasks, communicating project status


Experience Requirements:

  • Bachelor’s Degree in Engineering or equivalent
  • 2+ years experience in manufacturing engineering, preferably in medical, automotive, or aerospace
  • Ability to find common ground between various stakeholders and bring people together to drive towards key goals
  • Knowledgeable of GD&T (certification is a plus), 21 CFR part 820 and ISO 13485
  • Proficient in MS Office and ERP Information Systems (preferably SAP)
  • Ability to travel to suppliers on an as-needed basis (domestic & international)
  • The ideal candidate has experience bringing complex electro-mechanical devices market, has worked directly with manufacturing suppliers and component suppliers; and has demonstrated knowledge in a variety of manufacturing technologies.



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