Strong knowledge of statistics and minitab software
The primary purpose of this role is to apply intensive engineering knowledge to ensure NPI projects result in 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 quality products for medical device OEMs.
You will lead testing and validation of new test methods, including gage R&R studies and statistical analysis using software packages such as Minitab.
This position requires adherence to strict safety, environmental, security, and quality requirements including FDA regulations and ISO14971 standards.
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 OEMs.
Skills & Requirements
Must-have
Bachelor's degree in engineering or related field
7+ years of progressive engineering experience
Strong knowledge of statistics and Minitab software
Experience with ISO14971 risk management
Knowledge of 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
Familiarity with international standards like UL and MDD
Positive can-do attitude in high-energy environments
Key Requirements
Minimum Bachelor's degree in engineering
7+ years of relevant engineering experience
Six Sigma Green Belt minimum (Black Belt preferred)
Strong working knowledge of Statistics
Awareness of Domestic and International Regulations