Engineer, Senior - Npi*

Integer

Bachelor's degree in engineering
7+ years progressive engineering experience
Statistical analysis using minitab
The primary purpose of this role is to apply intensive engineering knowledge to ensure NPI projects result in quality products for medical device OEMs

Job Summary

  • The primary purpose of this role is to apply intensive engineering knowledge to ensure NPI projects result in quality products for medical device OEMs.
  • Candidates will lead testing and validation of new test methods, including gage R&R studies and statistical analysis using software like Minitab.
  • This position requires adherence to strict safety, environmental, security, and FDA regulatory requirements while supporting continuous improvement initiatives.

Matching Summary

The primary purpose of this role is to apply intensive engineering knowledge to ensure NPI projects result in quality products for medical device OEMs.

Skills & Requirements

Must-have

  • Bachelor's degree in engineering
  • 7+ years progressive engineering experience
  • Statistical analysis using Minitab
  • ISO14971 risk management knowledge
  • FDA regulations and QMS compliance
  • Root cause analysis and CAPA leadership
  • Test method development and validation

Nice-to-have

  • Master's degree in engineering
  • Six Sigma Black Belt certification
  • Mentoring and coaching engineers
  • Cross-functional team leadership
  • Continuous improvement mindset
  • Strong written and oral communication
  • Positive can-do attitude

Key Requirements

  • Bachelor's degree in engineering or related field
  • 7+ years of progressive 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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