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 New Product Introduction projects result in quality products for medical device OEMs

Job Summary

  • This role involves applying intensive engineering knowledge to ensure New Product Introduction projects result in quality products for medical device OEMs.
  • The engineer will lead testing, validation, and root cause analysis while ensuring compliance with FDA regulations and ISO standards.
  • Candidates are expected to mentor others, develop new test methods, and drive continuous improvement initiatives within a global organization.

Matching Summary

This role involves applying intensive engineering knowledge to ensure New Product Introduction projects result in 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
  • Test method development and validation

Nice-to-have

  • Master's degree in engineering
  • Six Sigma Black Belt certification
  • Experience mentoring engineers
  • Cross-functional team leadership
  • Continuous improvement mindset
  • Strong written and oral communication

Key Requirements

  • Minimum Bachelor's degree in engineering
  • 7+ years of relevant engineering experience
  • Six Sigma Green Belt (Black Belt preferred)
  • Knowledge of ISO, QSR, UL, MDD, TGA standards
  • Proficiency in Microsoft Office and Minitab

Work Rights

Not specified

Tailored Resume

Cover Letter