This role focuses on applying intensive engineering knowledge to ensure New Product Introduction projects meet quality standards for medical device OEMs
Job Summary
This role focuses on applying intensive engineering knowledge to ensure New Product Introduction projects meet quality standards for medical device OEMs.
The engineer will lead test method validation, root cause analysis, and continuous improvement initiatives while adhering to FDA and ISO regulations.
Candidates are expected to mentor other engineers, manage up to three direct reports, and drive the company's journey to 5 Sigma quality levels.
Matching Summary
This role focuses on applying intensive engineering knowledge to ensure New Product Introduction projects meet quality standards for medical device OEMs.
Skills & Requirements
Must-have
Bachelor's degree in engineering
7+ years progressive engineering experience
Strong statistical analysis skills with Minitab
Knowledge of ISO14971 risk management
Experience with FDA regulations and QMS
Leading cross-functional NPI projects
Root cause analysis and CAPA leadership
Nice-to-have
Master's degree in engineering
Six Sigma Black Belt certification
Mentoring and coaching engineers
Experience with supplier quality management
5S and workplace organization expertise
Positive can-do attitude in high energy environment
Key Requirements
Minimum Bachelor's degree in engineering
7+ years of relevant engineering experience
Six Sigma Green Belt required, Black Belt preferred