Engineer, Senior - Npi*

Integer

Not specified; not specified; not specified
Bachelor's degree in engineering
7+ years progressive engineering experience
Statistical analysis with minitab
The primary purpose of this role is to apply intensive engineering knowledge to ensure New Product Introduction 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 New Product Introduction projects result in high-quality products for medical device OEMs.
  • Candidates will lead testing and validation of new test methods, 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 ISO standards while supporting regulatory inspections.

Matching Summary

The primary purpose of this role is to apply intensive engineering knowledge to ensure New Product Introduction projects result in high-quality products for medical device OEMs.

Salary

Not specified; Not specified; Not specified

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 adherence
  • Root cause analysis and CAPA leadership

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 or related field
  • 7+ years of progressive engineering experience
  • Six Sigma Green Belt minimum, Black Belt preferred
  • Knowledge of ISO, QSR, UL, MDD, TGA regulations
  • Strong working knowledge of Statistics and Minitab

Work Rights

Not specified

Tailored Resume

Cover Letter