The primary purpose of this role is to apply intensive engineering knowledge to ensure New Product Introduction 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 New Product Introduction projects result in quality products for medical device and energy markets.
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, and quality requirements including FDA regulations and ISO14971 risk management activities.
Matching Summary
The primary purpose of this role is to apply intensive engineering knowledge to ensure New Product Introduction 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
6-Sigma Green Belt certification minimum
Minitab statistical software proficiency
ISO14971 risk management knowledge
FDA regulations and QMS compliance
Root cause analysis and CAPA leadership
Nice-to-have
Master's degree in engineering
Six Sigma Black Belt certification
Experience mentoring junior engineers
Cross-functional team leadership skills
Knowledge of international standards like UL and MDD
Strong written and oral communication skills
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
6-Sigma Green Belt certification required
Strong working knowledge of Statistics and Minitab
Awareness of Domestic and International Regulations