Engineer, Senior - Npi*

Integer

Not specified (assumed hybrid or onsite based on industry practices).
Bachelor's degree in engineering
7+ years progressive engineering experience
Minitab statistical software proficiency
Integer is seeking a Senior Engineer for New Product Introduction (NPI) who will apply advanced engineering principles to enhance product quality and innovation, while ensuring compliance with regulatory standards. The ideal candidate will possess both technical expertise and strong leadership qualities, contributing to continuous improvement and collaboration within the team

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.
  • Candidates will lead testing and validation of new test methods, including gage R&R studies and statistical analysis using Minitab.
  • This position requires supporting regulatory inspections, audits, and investigations while ensuring compliance with FDA regulations and ISO standards.

Matching Summary

Match Score: 85

Integer is seeking a Senior Engineer for New Product Introduction (NPI) who will apply advanced engineering principles to enhance product quality and innovation, while ensuring compliance with regulatory standards. The ideal candidate will possess both technical expertise and strong leadership qualities, contributing to continuous improvement and collaboration within the team.

Skills & Requirements

Must-have

  • Bachelor's degree in engineering
  • 7+ years progressive engineering experience
  • Minitab statistical software proficiency
  • ISO14971 risk management knowledge
  • FDA regulations and QMS adherence
  • Root cause analysis leadership
  • Test method validation protocols

Nice-to-have

  • Master's degree in engineering
  • Six Sigma Black Belt certification
  • Cross-functional team leadership
  • Supplier quality collaboration
  • Continuous improvement mindset
  • Mentoring junior engineers
  • 5 Sigma journey participation

Key Requirements

  • Minimum Bachelor's degree in engineering or related field
  • 7+ years of progressive engineering experience
  • Strong working knowledge of Statistics and Minitab
  • Awareness of Domestic and International Regulations (ISO, QSR, UL)
  • Green Belt Six Sigma minimum, Black Belt preferred

Work Rights

Not specified

Tailored Resume

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