Engineer, Senior - Npi*

Integer

Bachelor's degree in engineering
7+ years progressive engineering experience
Strong statistical analysis skills
The primary purpose of this role is to apply intensive engineering knowledge to ensure New Product Introduction projects result in high-quality products for medical device OEMs

Job Summary

  • The primary purpose of this role is to apply intensive engineering knowledge to ensure New Product Introduction projects result in high-quality products for medical device OEMs.
  • You will lead testing and validation of new test methods, including gage R&R studies and statistical analysis using Minitab, while coaching others on design and manufacture of tooling.
  • This position requires adherence to strict Quality Management Systems, FDA regulations, and ISO standards while supporting regulatory inspections and leading continuous improvement initiatives.

Matching Summary

The primary purpose of this role is to apply intensive engineering knowledge to ensure New Product Introduction projects result in high-quality products for medical device OEMs.

Skills & Requirements

Must-have

  • Bachelor's degree in engineering
  • 7+ years progressive engineering experience
  • Strong statistical analysis skills
  • Minitab software proficiency
  • ISO14971 risk management knowledge
  • FDA regulations and QMS compliance
  • Root cause analysis expertise

Nice-to-have

  • Master's degree preferred
  • Six Sigma Black Belt certification
  • Leadership of cross-functional teams
  • Mentoring junior engineers
  • 5 Sigma journey participation
  • Supplier quality collaboration

Key Requirements

  • Minimum Bachelor's degree in engineering
  • 7+ years of relevant engineering experience
  • Six Sigma Green Belt (Black Belt preferred)
  • Knowledge of ISO, QSR, UL, MDD, TGA standards
  • Strong working knowledge of Statistics

Work Rights

Not specified

Tailored Resume

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