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 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 core values of Customer, Innovation, and Integrity.
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 with Minitab
ISO14971 risk management knowledge
New Product Introduction (NPI) support
Root cause analysis and CAPA leadership
Nice-to-have
Master's degree in engineering field
Six Sigma Black Belt certification
Mentoring and coaching engineers
Cross-functional team leadership
Continuous improvement mindset
Strong written and oral communication
Key Requirements
Bachelor's degree in engineering or related field
Minimum 7 years of progressive engineering experience
Six Sigma Green Belt certification (Black Belt preferred)
Knowledge of ISO, QSR, UL, MDD, TGA regulations
Strong working knowledge of Statistics and Minitab