Engineer, Senior - Npi*

Integer

**
7+ years progressive engineering experience
Bachelor's degree in engineering field
Statistical analysis using minitab software
** Integer is seeking a Senior Engineer for New Product Introduction (NPI) with extensive engineering knowledge and experience in quality management, particularly in the medical device industry. The role emphasizes innovation, collaboration, and adherence to regulatory standards while supporting continuous improvement initiatives. **

Job Summary

  • The primary purpose of this role is to apply intensive engineering knowledge to ensure NPI projects result in high-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 strict safety, environmental, security, and quality requirements including FDA regulations and ISO standards.

Matching Summary

Match Score: 75

** Integer is seeking a Senior Engineer for New Product Introduction (NPI) with extensive engineering knowledge and experience in quality management, particularly in the medical device industry. The role emphasizes innovation, collaboration, and adherence to regulatory standards while supporting continuous improvement initiatives. **

Skills & Requirements

Must-have

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

Nice-to-have

  • Master's degree in engineering preferred
  • Six Sigma Black Belt certification
  • Experience mentoring engineering teams
  • Cross-functional project team leadership
  • Continuous improvement mindset
  • Strong written and oral communication

Key Requirements

  • Minimum 7 years of engineering experience
  • Bachelor's degree in engineering or related field
  • Six Sigma Green Belt minimum required
  • Knowledge of ISO, QSR, UL, MDD, TGA standards
  • Ability to work independently and collaboratively

Work Rights

Not specified

Tailored Resume

Cover Letter