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 efforts, including gage R&R studies and statistical analysis using software packages like Minitab.
The position requires adherence 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 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
Mentoring and coaching engineers
Cross-functional team leadership
Continuous improvement mindset
Positive can-do attitude
Key Requirements
Minimum Bachelor's degree in engineering or related field
7+ years of progressive engineering experience
Strong working knowledge of Statistics
Awareness of ISO, QSR, UL, MDD, TGA standards
Green belt Six Sigma minimum, Black belt preferred