Engineer, Senior - Npi*

813

Bachelor's degree in engineering
7+ years progressive engineering experience
Statistical analysis with minitab
The primary purpose of this role is to apply intensive engineering knowledge to ensure NPI projects result in high-quality products for medical devices and specialized batteries

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 devices and specialized batteries.
  • Candidates will lead testing and validation of new test methods, including gage R&R studies and statistical analysis using software packages like Minitab.
  • This position requires adherence to strict Quality Management Systems, FDA regulations, and ISO standards while supporting regulatory inspections and audits.

Matching Summary

The primary purpose of this role is to apply intensive engineering knowledge to ensure NPI projects result in high-quality products for medical devices and specialized batteries.

Skills & Requirements

Must-have

  • Bachelor's degree in Engineering
  • 7+ years progressive engineering experience
  • Statistical analysis with Minitab
  • ISO 14971 risk management knowledge
  • FDA regulations and QMS compliance
  • Root cause analysis and CAPA leadership
  • Test method validation and protocol writing

Nice-to-have

  • Master's degree in Engineering
  • Six Sigma Black Belt certification
  • Experience mentoring engineers
  • Cross-functional team leadership
  • Continuous improvement mindset
  • 5 Sigma journey participation

Key Requirements

  • Minimum Bachelor's degree in Engineering
  • 7+ years of relevant engineering experience
  • Strong working knowledge of Statistics
  • Familiarity with ISO, QSR, UL, MDD, TGA standards
  • Ability to work independently and collaboratively

Work Rights

Not specified

Tailored Resume

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