Manager, Manufacturing Engineering

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On-site
Bachelor's degree in engineering or science
10 years process design and development experience
Experience with heat staking ultrasonic laser welding
The role requires leading cross-functional teams to design and develop manufacturing processes for new medical device products

Job Summary

  • The role requires leading cross-functional teams to design and develop manufacturing processes for new medical device products.
  • Candidates must ensure compliance with 21 CFR 820 regulations including equipment qualification and process validation protocols.
  • The position involves managing project timelines, troubleshooting equipment downtime, and driving continuous improvement initiatives.

Matching Summary

The role requires leading cross-functional teams to design and develop manufacturing processes for new medical device products.

Skills & Requirements

Must-have

  • Bachelor's Degree in Engineering or Science
  • 10 years process design and development experience
  • Experience with heat staking ultrasonic laser welding
  • Knowledge of 21 CFR 820 Medical Device Quality System
  • Ability to create 3D engineering models and drawings

Nice-to-have

  • High-volume manufacturing environment experience
  • Six Sigma Green Belt Certification
  • Custom equipment design and procurement experience
  • Programming vision systems robotics and PLCs
  • Strong leadership and coaching abilities

Key Requirements

  • Minimum 10 years experience in process design
  • Bachelor's degree in technical discipline
  • Experience with medical device manufacturing technologies
  • Understanding of 21 CFR 820.70 and 820.75

Work Rights

Not specified

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