Engineer, Senior - Npi*

Integer

Bachelor's degree in engineering
7+ years progressive engineering experience
Statistical analysis using minitab
This role involves applying intensive engineering knowledge to ensure NPI projects result in high-quality products for medical device OEMs

Job Summary

  • This role involves applying intensive engineering knowledge to ensure NPI projects result in high-quality products for medical device OEMs.
  • The engineer will lead test method development, validation, and statistical analysis while ensuring compliance with FDA regulations and ISO standards.
  • Candidates are expected to mentor others, lead cross-functional teams, and drive continuous improvement initiatives aligned with the company's values.

Matching Summary

This role involves applying intensive engineering knowledge to ensure NPI projects result in high-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

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

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 ISO, QSR, UL, MDD, TGA regulations
  • Green belt Six Sigma minimum (Black belt preferred)

Work Rights

Not specified

Tailored Resume

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