Engineer, Senior - Npi*

Integer

**
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) to drive innovation and quality improvements in medical device manufacturing. The ideal candidate will possess extensive engineering experience, strong problem-solving skills, and a commitment to collaboration and continuous improvement. **

Job Summary

  • The primary purpose of this role is to apply intensive engineering knowledge to ensure NPI projects result in quality products for medical device OEMs.
  • You will lead testing and validation of new test methods, including gage R&R studies and statistical analysis using software packages such as Minitab.
  • As a subject matter expert, you are expected to coach others, mentor engineers, and drive continuous improvement projects while adhering to strict FDA and ISO regulations.

Matching Summary

Match Score: 75

** Integer is seeking a Senior Engineer for New Product Introduction (NPI) to drive innovation and quality improvements in medical device manufacturing. The ideal candidate will possess extensive engineering experience, strong problem-solving skills, and a commitment to collaboration and continuous improvement. **

Skills & Requirements

Must-have

  • Bachelor's degree in engineering
  • 7+ years progressive engineering experience
  • Statistical analysis using Minitab
  • ISO14971 risk management knowledge
  • Root cause analysis and CAPA leadership
  • Test method development and validation
  • FDA regulations and QMS compliance

Nice-to-have

  • Master's degree in engineering
  • Six Sigma Black Belt certification
  • Mentoring and coaching engineers
  • Cross-functional team leadership
  • Continuous improvement mindset
  • Strong written and oral communication
  • Positive can-do attitude

Key Requirements

  • Bachelor's degree in engineering or related field
  • 7+ years of progressive engineering experience
  • Six Sigma Green Belt (Black Belt preferred)
  • Knowledge of ISO, QSR, UL, MDD, TGA standards
  • Strong working knowledge of Statistics

Work Rights

Not specified

Tailored Resume

Cover Letter