This role involves applying intensive engineering knowledge to ensure New Product Introduction projects meet quality standards for medical device OEMs
Job Summary
This role involves applying intensive engineering knowledge to ensure New Product Introduction projects meet quality standards for medical device OEMs.
The successful candidate will lead test method validations, root cause analyses, and continuous improvement projects while adhering to FDA and ISO regulations.
You will serve as a subject matter expert in statistics and quality systems, coaching others and supporting regulatory inspections and audits.
Matching Summary
This role involves 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
6-Sigma Green Belt certification minimum
Minitab statistical analysis expertise
ISO14971 risk management knowledge
FDA regulations and QMS compliance
Root cause analysis leadership
Nice-to-have
Master's degree in engineering
Six Sigma Black Belt certification
Experience mentoring engineers
Cross-functional team leadership
Continuous improvement mindset
Strong written and oral communication
Positive can-do attitude
Key Requirements
Minimum Bachelor's degree in engineering or related field
7+ years of progressive engineering experience
6-Sigma Green Belt certification required
Knowledge of ISO, QSR, UL, MDD, TGA standards
Strong working knowledge of Statistics and Minitab