Engineer, Senior - Npi*

Integer

Not specified; not specified; not specified
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 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 efforts, including gage R&R studies and statistical analysis, while ensuring compliance with FDA regulations and ISO standards.
  • This position requires a subject matter expert with 7+ years of experience who can independently resolve complex problems and mentor other engineers within a values-driven culture.

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 using Minitab
  • ISO14971 risk management knowledge
  • FDA regulations and QMS compliance
  • Root cause analysis and CAPA leadership
  • Cross-functional project team leadership

Nice-to-have

  • Master's degree in engineering
  • Six Sigma Black Belt certification
  • Mentoring and coaching engineers
  • 5 Sigma journey participation
  • Strong written and oral communication
  • Positive can-do attitude
  • Experience with supplier quality

Key Requirements

  • Minimum Bachelor's degree in Engineering
  • 7+ years of relevant engineering experience
  • Six Sigma Green Belt minimum required
  • Knowledge of ISO, QSR, UL, MDD standards
  • Proficiency in Microsoft Office and Minitab

Work Rights

Not specified

Tailored Resume

Cover Letter