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 regulatory inspections and audits.
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
Statistical analysis with Minitab
ISO14971 risk management knowledge
FDA regulations and QMS compliance
Root cause analysis and CAPA leadership
Process validation and capability studies
Nice-to-have
Master's degree in engineering
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 (Black Belt preferred)
Knowledge of ISO, QSR, UL, MDD, TGA standards
U.S. citizenship or work authorization not specified