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 support the development and validation of innovative medical device technologies. The ideal candidate will possess strong technical skills, leadership qualities, and a commitment to quality and regulatory compliance. **

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.
  • Candidates will lead testing and validation of new test methods, including gage R&R studies and statistical analysis using software packages like Minitab.
  • The successful candidate must adhere to all safety, environmental, security, and quality requirements including FDA regulations and ISO standards while supporting continuous improvement initiatives.

Matching Summary

Match Score: 75

** Integer is seeking a Senior Engineer for New Product Introduction (NPI) to support the development and validation of innovative medical device technologies. The ideal candidate will possess strong technical skills, leadership qualities, and a commitment to quality and regulatory compliance. **

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
  • Test method development and validation

Nice-to-have

  • Master's degree in engineering field
  • Six Sigma Black Belt certification
  • Experience mentoring junior engineers
  • Cross-functional team leadership skills
  • Knowledge of international standards (UL, MDD)
  • Positive can-do attitude under pressure

Key Requirements

  • Minimum Bachelor's degree in engineering or related field
  • 7+ years of progressive engineering experience
  • Strong working knowledge of Statistics and Minitab
  • Awareness of Domestic and International Regulations (ISO, QSR, UL)

Work Rights

Not specified

Tailored Resume

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