Engineer, Senior - Npi*

Integer

Hybrid
Bachelor's degree in engineering
7+ years progressive engineering experience
Statistical analysis using minitab
Integer is seeking a Senior Engineer for New Product Introduction (NPI) who will apply advanced engineering principles to ensure product quality and compliance in the medical device industry. The role emphasizes collaboration, innovation, and adherence to safety and regulatory standards

Job Summary

  • This role involves applying intensive engineering knowledge to ensure New Product Introduction projects meet quality standards for medical device OEMs.
  • The successful candidate will lead test method development, validation studies, and root cause analysis while adhering to FDA and ISO regulations.
  • You will serve as a subject matter expert in statistics and quality systems, coaching teams and driving continuous improvement initiatives.

Matching Summary

Match Score: 85

Integer is seeking a Senior Engineer for New Product Introduction (NPI) who will apply advanced engineering principles to ensure product quality and compliance in the medical device industry. The role emphasizes collaboration, innovation, and adherence to safety and regulatory standards.

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
  • Six Sigma Black Belt certification
  • Experience mentoring junior engineers
  • Cross-functional team leadership
  • Continuous improvement mindset

Key Requirements

  • Bachelor's degree in engineering or related field
  • Minimum 7 years of progressive engineering experience
  • Strong working knowledge of Statistics and Minitab
  • Awareness of ISO, QSR, UL, MDD, TGA regulations
  • Green Belt Six Sigma required; Black Belt preferred

Work Rights

Not specified

Tailored Resume

Cover Letter