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 validations, statistical analyses using Minitab, and root cause investigations while ensuring compliance with FDA regulations.
Candidates are expected to mentor other engineers, lead cross-functional teams, and drive continuous improvement initiatives aligned with the company's values.
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
Statistical analysis using Minitab
ISO14971 risk management knowledge
FDA regulations and QMS compliance
Root cause analysis and CAPA leadership
Test method development and validation
Nice-to-have
Master's degree in engineering
Six Sigma Black Belt certification
Mentoring and coaching engineers
Cross-functional team leadership
Continuous improvement mindset
Strong written and oral communication
Key Requirements
Bachelor's degree in engineering or related field
Minimum 7 years of progressive engineering experience
Six Sigma Green Belt (Black Belt preferred)
Knowledge of ISO, QSR, UL, MDD, TGA standards
Strong working knowledge of statistics and Minitab