Sr Manufacturing Mechanical Engineer - Shockwave

Johnson & Johnson Innovative Medicine

Santa Clara, CA, US
Base: $89,000 to $142,600 annually; bonus/equity: ...
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Process/manufacturing development
Validation protocols and reports
Process risk documentation (pfmea)
** Johnson & Johnson is seeking a Senior Manufacturing Mechanical Engineer for their Shockwave Medical team in Santa Clara, CA. This role focuses on providing technical support for the manufacturing and validation of innovative medical devices aimed at treating cardiovascular diseases. **

Job Summary

  • Responsible for technical support to contract manufacturers and component suppliers on the implementation and validation of manufacturing lines for Shockwave products.
  • Develops and maintains process risk documentation (e.g., PFMEA) to identify potential risks and implement preventive and corrective actions.
  • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements (ISO), Company policies, operating procedures, processes, and task assignments.

Matching Summary

Match Score: 75

** Johnson & Johnson is seeking a Senior Manufacturing Mechanical Engineer for their Shockwave Medical team in Santa Clara, CA. This role focuses on providing technical support for the manufacturing and validation of innovative medical devices aimed at treating cardiovascular diseases. **

Salary

Base: $89,000 to $142,600 annually; Bonus/Equity: Eligible for annual performance bonus; Benefits: Medical, dental, vision, life insurance, disability, retirement plan, savings plan, paid time off

Skills & Requirements

Must-have

  • Process/Manufacturing development
  • Validation protocols and reports
  • Process risk documentation (PFMEA)
  • Lean manufacturing tools
  • Design for Manufacturability (DFM)
  • Product failure investigations

Nice-to-have

  • 3D Printing and Material selection
  • Braiding, coiling & laser processing
  • Program Management experience

Key Requirements

  • Bachelor’s degree in Mechanical Engineering or related field
  • 5 years of experience in Process/Manufacturing development
  • Experience with regulated product environments
  • Experience with balloon/stent catheter manufacturing
  • Ability to travel abroad

Work Rights

Not specified

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