Engineer, Senior - Npi*

Integer

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

Job Summary

  • The primary purpose of this role is to apply intensive engineering knowledge to ensure NPI projects result in high-quality products for medical device OEMs and specialized battery markets.
  • Candidates will lead test method development, validate processes using statistical tools like Minitab, and manage root cause analysis for non-conforming materials.
  • This position requires adherence to strict FDA regulations, ISO standards, and Integer's core values while potentially supervising up to three direct reports.

Matching Summary

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

Skills & Requirements

Must-have

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

Nice-to-have

  • Master's degree in engineering
  • Six Sigma Black Belt certification
  • Experience mentoring engineering teams
  • Cross-functional project leadership
  • Continuous improvement mindset
  • Strong written and oral communication

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
  • Proficiency in Microsoft Office and Minitab

Work Rights

Not specified

Tailored Resume

Cover Letter