This role involves applying intensive engineering knowledge to ensure New Product Introduction projects result in high-quality products for medical device OEMs
Job Summary
This role involves applying intensive engineering knowledge to ensure New Product Introduction projects result in high-quality products for medical device OEMs.
The successful candidate will lead test method validations, conduct gage R&R studies, and provide technical input on root cause analysis for product failures.
You will serve as a standard bearer for Quality by ensuring adherence to the Quality Management System and supporting continuous improvement initiatives toward 5 Sigma.
Matching Summary
This role involves applying intensive engineering knowledge to ensure New Product Introduction projects result in high-quality products for medical device OEMs.
Skills & Requirements
Must-have
7+ years progressive engineering experience
Bachelor's degree in engineering or related field
Strong statistical analysis skills with Minitab
Experience with ISO14971 risk management
Knowledge of FDA regulations and QMS
Leading cross-functional NPI project teams
Nice-to-have
Master's degree in engineering
Six Sigma Black Belt certification
Mentoring and coaching junior engineers
Experience with supplier quality management
Positive can-do attitude in high energy environment
Key Requirements
Minimum 7 years of engineering experience
Bachelor's degree required; Master's preferred
Six Sigma Green Belt minimum, Black Belt preferred