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.