The primary purpose of this role is to apply intensive engineering knowledge to ensure NPI projects result in quality products for medical device and energy markets
Job Summary
The primary purpose of this role is to apply intensive engineering knowledge to ensure NPI projects result in quality products for medical device and energy markets.
Candidates will lead testing and validation of new test methods, including gage R&R studies and statistical analysis using software packages like Minitab.
This position requires adherence to strict regulatory requirements including FDA regulations, ISO standards, and the company's core values of Customer, Innovation, and Integrity.
Matching Summary
The primary purpose of this role is to apply intensive engineering knowledge to ensure NPI projects result in quality products for medical device and energy markets.
Skills & Requirements
Must-have
Bachelor's degree in engineering
7+ years progressive engineering experience
Strong statistical analysis skills with Minitab
Knowledge of ISO14971 risk management
Experience with FDA regulations and QMS
Ability to lead cross-functional project teams
Nice-to-have
Master's degree in engineering
Six Sigma Black Belt certification
Experience mentoring junior engineers
Background in medical device OEMs
Positive can-do attitude in high-energy environments
Key Requirements
Minimum Bachelor's degree in engineering or related field
7+ years of progressive engineering experience
Six Sigma Green Belt minimum (Black Belt preferred)
Working knowledge of Microsoft Office and Minitab
Awareness of domestic and international industry standards