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 efforts, including gage R&R studies and statistical analysis using Minitab to support process improvements.
The successful engineer will coach cross-functional teams, manage CAPA activities, and ensure strict adherence to FDA regulations and ISO 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.
Salary
Not specified; Not specified; Not specified
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
Design of Experiments (DOE) expertise
Nice-to-have
Master's degree in engineering field
Six Sigma Black Belt certification
Cross-functional team leadership skills
Strong written and oral communication
Positive can-do attitude
Experience with supplier quality analysis
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 ISO, QSR, UL, MDD, TGA standards
Strong working knowledge of Statistics and Minitab