Engineer, Senior - Npi*

Integer

Not specified; not specified; not specified
Not specified (assumed to be hybrid 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 its New Product Introduction (NPI) team. The ideal candidate will have extensive engineering experience, specializing in quality management and product development within the medical device industry, and will embody Integer's core values of customer focus, innovation, collaboration, and integrity

Job Summary

  • The primary purpose of this role is to apply intensive engineering knowledge to ensure New Product Introduction 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 all safety, environmental, security, and quality requirements including FDA regulations and ISO standards while supporting regulatory inspections.

Matching Summary

Match Score: 85

Integer is seeking a Senior Engineer for its New Product Introduction (NPI) team. The ideal candidate will have extensive engineering experience, specializing in quality management and product development within the medical device industry, and will embody Integer's core values of customer focus, innovation, collaboration, and integrity.

Salary

Not specified; Not specified; Not specified

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 validation and gage R&R

Nice-to-have

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

Key Requirements

  • Minimum Bachelor's degree in Engineering
  • 7+ years of relevant engineering experience
  • Six Sigma Green Belt minimum required
  • Knowledge of ISO, QSR, UL, MDD standards
  • Strong working knowledge of Statistics

Work Rights

Not specified

Tailored Resume

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