This role involves applying intensive engineering knowledge to ensure New Product Introduction projects meet quality expectations for medical device OEMs
Job Summary
This role involves applying intensive engineering knowledge to ensure New Product Introduction projects meet quality expectations for medical device OEMs.
The engineer will lead test method development, validation studies, and root cause analysis while adhering to strict FDA and ISO regulatory requirements.
Candidates are expected to mentor others, lead cross-functional teams, and drive continuous improvement initiatives aligned with the company's values.
Matching Summary
This role involves applying intensive engineering knowledge to ensure New Product Introduction projects meet quality expectations for medical device OEMs.
Skills & Requirements
Must-have
Bachelor's degree in engineering or related field
7+ years of progressive engineering experience
Strong statistical analysis skills with Minitab
Knowledge of ISO14971 risk management standards
Experience with FDA regulations and QMS
Nice-to-have
Master's degree in engineering preferred
Six Sigma Black Belt certification
Experience mentoring junior engineers
Background in battery manufacturing
Ability to work independently on complex problems
Key Requirements
Minimum Bachelor's degree in engineering
7+ years of relevant engineering experience
Six Sigma Green Belt minimum (Black Belt preferred)