Engineer, Senior - Npi*

Integer

7+ years progressive engineering experience
Bachelor's degree in engineering field
Minitab statistical software expertise
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 successful candidate will lead testing, validation, and root cause analysis while ensuring strict adherence to FDA regulations and ISO standards.
  • You will serve as a subject matter expert in statistics, utilizing Minitab for gage R&R studies and driving continuous improvement initiatives.

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

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

Nice-to-have

  • Six Sigma Black Belt certification
  • Master's degree in engineering
  • Cross-functional team leadership skills
  • Mentoring and coaching abilities
  • 5 Sigma quality journey participation

Key Requirements

  • Minimum Bachelor's degree in engineering
  • 7+ years of progressive engineering experience
  • Six Sigma Green Belt (Black Belt preferred)
  • Strong working knowledge of Statistics
  • Experience with Minitab software
  • Knowledge of ISO, QSR, UL, MDD, TGA standards

Work Rights

Not specified

Tailored Resume

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