This role involves applying intensive engineering knowledge to ensure New Product Introduction projects meet quality standards for medical devices and specialized batteries
Job Summary
This role involves applying intensive engineering knowledge to ensure New Product Introduction projects meet quality standards for medical devices and specialized batteries.
The successful candidate will lead test method development, validation studies, and statistical analysis using tools like Minitab while ensuring compliance with FDA regulations.
You will serve as a subject matter expert, coaching others on quality systems, leading root cause investigations, and driving continuous improvement initiatives across the organization.
Matching Summary
This role involves applying intensive engineering knowledge to ensure New Product Introduction projects meet quality standards for medical devices and specialized batteries.
Skills & Requirements
Must-have
Bachelor's degree in engineering or related field
7+ years progressive engineering experience
Strong knowledge of statistics and Minitab
Experience with ISO14971 risk management
Knowledge of FDA regulations and QMS
Ability to lead cross-functional project teams
Expertise in root cause analysis and CAPA
Nice-to-have
Master's degree in engineering
Six Sigma Black Belt certification
Experience mentoring junior engineers
Background in medical device OEMs
Familiarity with international standards like UL and MDD
Proven track record in continuous improvement
Experience with supplier quality management
Key Requirements
Minimum Bachelor's degree in engineering
7+ years of relevant engineering experience
Six Sigma Green Belt required, Black Belt preferred
Working knowledge of FDA regulations and QMS
Statistical expertise including Cpk, DOE, and Hypotheses Testing