The role focuses on applying intensive engineering knowledge to ensure New Product Introduction projects result in high-quality products for medical device OEMs
Job Summary
The role focuses on applying intensive engineering knowledge to ensure New Product Introduction projects result in high-quality products for medical device OEMs.
Candidates will lead testing validation, root cause analysis, and continuous improvement projects while ensuring compliance with FDA regulations and Quality Management Systems.
This position requires a subject matter expert who can coach others, manage cross-functional teams, and drive the organization toward 5 Sigma quality goals.
Matching Summary
The role focuses on applying intensive engineering knowledge to ensure New Product Introduction projects result in high-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 engineering teams
Knowledge of ISO, UL, MDD standards
Cross-functional project team leadership
Key Requirements
Minimum Bachelor's degree in engineering or related field
7+ years of progressive engineering experience
Strong working knowledge of Statistics and Minitab
Awareness of Domestic and International Regulations (ISO, QSR, UL)
Green Belt Six Sigma minimum, Black Belt preferred