The role focuses on applying intensive engineering knowledge to ensure New Product Introduction projects meet quality expectations for medical device OEMs
Job Summary
The role focuses on applying intensive engineering knowledge to ensure New Product Introduction projects meet quality expectations for medical device OEMs.
Candidates will lead testing, validation, and root cause analysis while ensuring compliance with FDA regulations and ISO standards.
This position requires mentoring others, managing up to three direct reports, and driving continuous improvement initiatives within a global organization.
Matching Summary
The role focuses on applying intensive engineering knowledge to ensure New Product Introduction projects meet quality expectations 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
Knowledge of ISO14971 risk management standards
Experience with FDA regulations and QMS
Ability to lead cross-functional project teams
Proficiency in developing test methods and protocols
Nice-to-have
Master's degree in engineering preferred
Six Sigma Black Belt certification
Mentoring and coaching junior engineers
Experience with supplier quality management
Positive can-do attitude in high-energy environments
Fluency in English for international communication
Key Requirements
Minimum 7+ years of engineering experience
Bachelor's degree required; Master's preferred
Six Sigma Green Belt minimum; Black Belt preferred
Work authorization status not specified
Strong background in statistical tools like Minitab