The primary purpose of this role is to apply intensive engineering knowledge to ensure NPI projects result in quality products for medical device OEMs
Job Summary
The primary purpose of this role is to apply intensive engineering knowledge to ensure NPI projects result in quality products for medical device OEMs.
Candidates will lead testing, validation, and root cause analysis while coaching teams on new test methods and tooling design.
The position requires adherence to strict safety, environmental, and FDA regulations while driving continuous improvement towards 5 Sigma quality goals.
Matching Summary
The primary purpose of this role is to apply intensive engineering knowledge to ensure NPI projects result in quality products for medical device OEMs.
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 development and validation
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
Bachelor's degree in engineering or related field
Minimum 7 years of progressive engineering experience
Six Sigma Green Belt minimum, Black Belt preferred
Working knowledge of statistics and Minitab software