The primary purpose of this role is to apply intensive engineering knowledge to ensure NPI projects result in high-quality products for medical devices
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 devices.
You will lead testing and validation of new test methods, including gage R&R studies and statistical analysis using software packages like Minitab.
As a senior engineer, you are expected to coach and mentor others while ensuring compliance with FDA regulations and the company's Quality Management System.
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 devices.
Skills & Requirements
Must-have
7+ years progressive engineering experience
Bachelor's degree in engineering or related field
Strong statistical analysis skills with Minitab
ISO14971 risk management knowledge
FDA regulations and QMS compliance
Root cause analysis and CAPA leadership
Test method validation and protocol writing
Nice-to-have
Master's degree in engineering preferred
Six Sigma Black Belt certification
Experience mentoring junior engineers
Knowledge of ISO, UL, MDD, TGA standards
5S workplace organization expertise
Cross-functional team leadership abilities
Continuous improvement mindset
Key Requirements
Minimum 7 years of engineering experience
Bachelor's degree required (Master's preferred)
Six Sigma Green Belt minimum (Black Belt preferred)