The primary purpose of this role is to apply intensive engineering knowledge to ensure New Product Introduction 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 New Product Introduction 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 packages like Minitab.
The successful candidate must adhere to strict safety, environmental, and FDA regulatory requirements while supporting internal and external audits and investigations.
Matching Summary
The primary purpose of this role is to apply intensive engineering knowledge to ensure New Product Introduction 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
Test method validation and gage R&R
Nice-to-have
Master's degree in engineering
Six Sigma Black Belt certification
Experience mentoring engineers
Cross-functional team leadership
Continuous improvement mindset
Strong written and oral communication
Supplier quality collaboration
Key Requirements
Minimum Bachelor's degree in engineering
7+ years of relevant engineering experience
Six Sigma Green Belt minimum required
Knowledge of ISO, QSR, UL, MDD standards
US citizenship or work authorization not specified