Engineer, Senior - Npi*

809

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

Job Summary

  • This role focuses on applying intensive engineering knowledge to ensure New Product Introduction projects result in high-quality products for medical device OEMs.
  • The successful candidate will lead test method development, validation studies, and root cause analysis while ensuring strict adherence to FDA regulations and ISO standards.
  • You will serve as a subject matter expert in statistics and quality systems, coaching others and driving continuous improvement initiatives within a global organization.

Matching Summary

This role focuses on applying 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
  • 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 junior engineers
  • Cross-functional team leadership skills
  • 5 Sigma quality journey participation

Key Requirements

  • Minimum Bachelor's degree in engineering
  • 7+ years of relevant engineering experience
  • Strong proficiency with Minitab software
  • Knowledge of ISO, QSR, UL, MDD standards
  • Ability to work independently and collaboratively

Work Rights

Not specified

Tailored Resume

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