The primary purpose of this role is to apply intensive engineering knowledge to ensure NPI projects result in high-quality products for medical device OEMs
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 device OEMs.
Candidates will lead testing validation, root cause analysis, and continuous improvement projects while adhering to strict FDA and ISO regulatory requirements.
This position offers the opportunity to mentor other engineers and drive the company's journey toward 5 Sigma quality 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 device OEMs.
Skills & Requirements
Must-have
Bachelor's degree in engineering
7+ years progressive engineering experience
Minitab statistical software proficiency
ISO14971 risk management knowledge
FDA regulations and QMS compliance
Root cause analysis leadership
Nice-to-have
Master's degree in engineering field
Six Sigma Black Belt certification
Cross-functional team coaching skills
5 Sigma quality journey mindset
Supplier quality capability studies
Key Requirements
Bachelor's degree in engineering or related field
7+ years of progressive engineering experience
Six Sigma Green Belt minimum (Black Belt preferred)
Strong working knowledge of statistics and Minitab