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 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 safety, environmental, security, and quality requirements including FDA regulations and ISO standards while supporting continuous improvement initiatives.
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
Statistical analysis using Minitab
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
Strong written and oral communication
Positive can-do attitude under pressure
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)
Knowledge of Domestic and International Regulations (ISO, QSR, UL, MDD)