The primary purpose of this role is to apply intensive engineering knowledge to ensure NPI projects result in high-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 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 like Minitab.
The successful candidate must adhere to strict safety, environmental, and FDA regulations while supporting continuous improvement and quality KPI attainment.
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 device OEMs.
Skills & Requirements
Must-have
Bachelor's degree in engineering
7+ years progressive engineering experience
Minitab statistical analysis expertise
ISO14971 risk management knowledge
FDA QSR regulatory compliance
Root cause analysis leadership
Test method validation protocols
Nice-to-have
Master's degree in engineering
Six Sigma Black Belt certification
Cross-functional team leadership
Continuous improvement mindset
Strong written and oral communication
Positive can-do attitude
Mentoring junior engineers
Key Requirements
Bachelor's degree in engineering or related field
Minimum 7 years of progressive engineering experience
Six Sigma Green Belt required, Black Belt preferred
Knowledge of ISO, QSR, UL, MDD, TGA standards
Strong working knowledge of statistics and Minitab