Engineer, Senior - Npi*

Integer

Not specified; not specified; not specified
Bachelor's degree in engineering
7+ years progressive engineering experience
Statistical analysis using minitab
The primary purpose of this role is to apply intensive engineering knowledge to ensure NPI projects result in quality products while adhering to strict FDA and ISO regulations

Job Summary

  • The primary purpose of this role is to apply intensive engineering knowledge to ensure NPI projects result in quality products while adhering to strict FDA and ISO regulations.
  • Candidates will lead testing and validation efforts, including gage R&R studies and statistical analysis, while coaching others on new test methods and tooling design.
  • This position requires a subject matter expert with 7+ years of experience to drive continuous improvement, manage non-conforming materials, and support site quality audit activities.

Matching Summary

The primary purpose of this role is to apply intensive engineering knowledge to ensure NPI projects result in quality products while adhering to strict FDA and ISO regulations.

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 adherence
  • 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 junior engineers
  • Cross-functional team leadership skills
  • Knowledge of international standards (UL, MDD)
  • Strong written and oral communication
  • Positive can-do attitude in high energy

Key Requirements

  • Minimum Bachelor's degree in Engineering
  • 7+ years of progressive engineering experience
  • Six Sigma Green Belt minimum required
  • Strong working knowledge of Statistics
  • Ability to work independently and collaboratively

Work Rights

Not specified

Tailored Resume

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