The primary purpose of this role is to apply intensive engineering knowledge to ensure New Product Introduction projects result in 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 quality products for medical device OEMs.
Candidates will lead testing validation, root cause analysis, and process improvements while adhering to FDA regulations and ISO standards.
This position requires a subject matter expert with 7+ years of experience who can independently manage technical projects and mentor junior engineers.
Matching Summary
The primary purpose of this role is to apply intensive engineering knowledge to ensure New Product Introduction projects result in 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
Experience mentoring engineers
Cross-functional team leadership
Continuous improvement mindset
Key Requirements
Bachelor's degree in engineering or related field
Minimum 7 years of progressive engineering experience
Strong working knowledge of statistics and Minitab
Awareness of ISO, QSR, UL, MDD, TGA regulations
Green belt Six Sigma minimum, Black belt preferred