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.
You will lead testing and validation of new test methods, including gage R&R studies and statistical analysis using software packages such as Minitab.
This position requires adherence to strict Quality Management Systems, FDA regulations, and ISO standards while supporting regulatory inspections and audits.
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
Nice-to-have
Master's degree in engineering
Six Sigma Black Belt certification
Experience mentoring engineers
Cross-functional team leadership
Continuous improvement mindset
Key Requirements
Minimum Bachelor's degree in engineering or related field
7+ years of progressive engineering experience
Strong working knowledge of Statistics and Minitab
Awareness of ISO, QSR, UL, MDD, TGA regulations
Green Belt Six Sigma required; Black Belt preferred