Engineer, Senior - Npi*

Integer

Bachelor's degree in engineering
7+ years progressive engineering experience
6-sigma green belt certification minimum
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.
  • Candidates 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.
  • This position requires adherence to strict Quality Management Systems, FDA regulations, and ISO standards while supporting regulatory inspections and audits.

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
  • 6-Sigma Green Belt certification minimum
  • Minitab statistical software proficiency
  • ISO14971 risk management knowledge
  • FDA regulations and QMS compliance
  • Root cause analysis and CAPA leadership

Nice-to-have

  • Master's degree in engineering field
  • Six Sigma Black Belt certification
  • Experience mentoring engineering teams
  • Cross-functional project team leadership
  • Continuous improvement culture mindset
  • Supplier quality capability studies
  • 5 Sigma journey participation

Key Requirements

  • Minimum Bachelor's degree in engineering
  • 7+ years of relevant engineering experience
  • 6-Sigma Green Belt certification required
  • Strong working knowledge of Statistics
  • Ability to work independently and collaboratively

Work Rights

Not specified

Tailored Resume

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