Engineer, Senior - Npi*

171

Not specified (assumed to be hybrid or onsite based on industry norms).
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 leverage extensive engineering knowledge to ensure high-quality product development and compliance with industry standards. The ideal candidate will have a strong technical background, at least 7 years of experience, and be proficient in problem-solving methodologies such as Six Sigma

Job Summary

  • This role involves applying intensive engineering knowledge to ensure New Product Introduction projects result in high-quality products for medical device OEMs.
  • The engineer will lead test method validations, gage R&R studies, and statistical analysis using software packages like Minitab to support product integrity.
  • Candidates must adhere to strict Quality Management Systems, FDA regulations, and ISO standards while driving continuous improvement and safety initiatives.

Matching Summary

Match Score: 85

Integer is seeking a Senior Engineer for New Product Introduction (NPI) who will leverage extensive engineering knowledge to ensure high-quality product development and compliance with industry standards. The ideal candidate will have a strong technical background, at least 7 years of experience, and be proficient in problem-solving methodologies such as Six Sigma.

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
  • Mentoring and coaching engineers
  • Cross-functional project team leadership
  • Continuous improvement culture mindset

Key Requirements

  • Minimum Bachelor's degree in Engineering
  • 7+ years of relevant engineering experience
  • Strong working knowledge of Statistics
  • Experience with Minitab software
  • Awareness of ISO, QSR, UL, MDD regulations

Work Rights

Not specified

Tailored Resume

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