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.
This position requires adherence to strict regulatory requirements including FDA regulations, ISO standards, and the company's six core values.
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.
Salary
Not specified; Not specified; Not specified
Skills & Requirements
Must-have
Bachelor's degree in engineering
7+ years progressive engineering experience
Statistical analysis with Minitab
ISO14971 risk management knowledge
Root cause analysis and CAPA leadership
Test method validation protocols
Nice-to-have
Master's degree in engineering
Six Sigma Black Belt certification
Mentoring and coaching engineers
Cross-functional team leadership
5 Sigma quality journey participation
Key Requirements
Bachelor's degree in engineering or related field
7+ years of progressive engineering experience
Six Sigma Green Belt minimum (Black Belt preferred)
Knowledge of QSR, ISO, UL, MDD, TGA regulations
Strong working knowledge of Statistics and Minitab