The primary purpose of this role is to apply intensive engineering knowledge to ensure NPI projects result in high-quality products for medical devices and specialized batteries
Job Summary
The primary purpose of this role is to apply intensive engineering knowledge to ensure NPI projects result in high-quality products for medical devices and specialized batteries.
Candidates will lead test method development, validate new processes, and conduct statistical analyses using tools like Minitab to support regulatory compliance and product integrity.
This position requires a subject matter expert with 7+ years of experience who can independently manage complex problems while adhering to strict FDA and ISO standards.
Matching Summary
The primary purpose of this role is to apply intensive engineering knowledge to ensure NPI projects result in high-quality products for medical devices and specialized batteries.
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 validation and gage R&R
Nice-to-have
Master's degree in engineering
Six Sigma Black Belt certification
Experience with supplier quality management
Cross-functional team leadership skills
Mentoring and coaching capabilities
5 Sigma journey participation
Positive can-do attitude
Key Requirements
Bachelor's degree in engineering or related field
7+ years of progressive engineering experience
Six Sigma Green Belt minimum (Black Belt preferred)
Knowledge of ISO, QSR, UL, MDD, TGA regulations
Strong working knowledge of statistics and Minitab