Engineer, Senior - Npi*

Integer

Not specified
Bachelor's degree in engineering
7+ years progressive engineering experience
Statistical analysis with minitab
Integer is seeking a Senior Engineer for New Product Introduction (NPI) who will play a critical role in applying engineering principles to ensure quality and compliance in product development for medical devices. The ideal candidate will have extensive experience in engineering, particularly in quality management systems and regulatory compliance. ###

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 using software packages like Minitab.
  • This position requires adherence to strict Quality Management Systems, FDA regulations, and safety requirements while supporting continuous improvement initiatives.

Matching Summary

Match Score: 85

Integer is seeking a Senior Engineer for New Product Introduction (NPI) who will play a critical role in applying engineering principles to ensure quality and compliance in product development for medical devices. The ideal candidate will have extensive experience in engineering, particularly in quality management systems and regulatory compliance. ###

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 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
  • Positive can-do attitude under pressure

Key Requirements

  • Minimum Bachelor's degree in engineering
  • 7+ years of relevant engineering experience
  • Strong working knowledge of Statistics
  • Awareness of ISO, QSR, UL, MDD standards
  • Ability to work independently and collaboratively

Work Rights

Not specified

Tailored Resume

Cover Letter