Engineer, Senior - Npi*

Integer

Bachelor's degree in engineering
7+ years progressive engineering experience
Statistical analysis using minitab
The primary purpose of this role is to apply intensive engineering knowledge to ensure NPI projects result in high-quality products for medical device OEMs

Job Summary

  • The primary purpose of this role is to apply intensive engineering knowledge to ensure NPI projects result in high-quality products for medical device OEMs.
  • Candidates will lead testing and validation efforts, including gage R&R studies and statistical analysis using software packages like Minitab.
  • This position requires adherence to strict safety, environmental, and quality requirements including FDA regulations and ISO14971 risk management activities.

Matching Summary

The primary purpose of this role is to apply 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 junior engineers
  • Cross-functional team leadership skills
  • Knowledge of ISO and UL standards
  • Strong written and oral communication

Key Requirements

  • Minimum Bachelor's degree in engineering
  • 7+ years of relevant engineering experience
  • Six Sigma Green Belt minimum required
  • Work authorization status not specified

Work Rights

Not specified

Tailored Resume

Cover Letter