Engineer, Senior - Npi*

442

Bachelor's degree in engineering
7+ years progressive engineering experience
Statistical analysis with minitab
This role involves applying intensive engineering knowledge to ensure New Product Introduction projects meet quality standards for medical device OEMs

Job Summary

  • This role involves applying intensive engineering knowledge to ensure New Product Introduction projects meet quality standards for medical device OEMs.
  • The engineer will lead testing, validation, and statistical analysis using tools like Minitab while ensuring compliance with FDA regulations and ISO standards.
  • Candidates are expected to mentor other engineers, lead cross-functional teams, and drive continuous improvement initiatives within a values-driven culture.

Matching Summary

This role involves applying intensive engineering knowledge to ensure New Product Introduction projects meet quality standards for medical device OEMs.

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 leadership

Nice-to-have

  • Master's degree in engineering
  • Six Sigma Black Belt certification
  • Mentoring and coaching engineers
  • Cross-functional team leadership
  • Continuous improvement mindset

Key Requirements

  • Minimum Bachelor's degree in engineering
  • 7+ years of relevant engineering experience
  • Strong working knowledge of statistics
  • Experience with ISO and QSR regulations
  • Ability to work independently and collaboratively

Work Rights

Not specified

Tailored Resume

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