The primary purpose of this role is to apply intensive engineering knowledge to ensure NPI projects result in quality products for medical device manufacturers
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 manufacturers.
Candidates will lead testing and validation of new test methods, including gage R&R studies and statistical analysis using Minitab.
The successful candidate must adhere to strict safety, environmental, and FDA regulatory requirements while mentoring other engineers.
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 manufacturers.
Skills & Requirements
Must-have
Bachelor's degree in engineering
7+ years progressive engineering experience
Minitab statistical software expertise
ISO14971 risk management knowledge
FDA regulations and QMS compliance
Nice-to-have
Master's degree in engineering
Six Sigma Black Belt certification
Leadership of cross-functional teams
Experience with medical device OEMs
Strong written and oral communication
Key Requirements
Minimum Bachelor's degree in engineering or related field
7+ years of progressive engineering experience
Strong working knowledge of Statistics and Minitab