The primary purpose of this role is to apply intensive engineering knowledge to ensure New Product Introduction 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 New Product Introduction 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, while coaching others on new test methods and tooling design.
This position requires adherence to strict safety, environmental, and FDA regulations while driving continuous improvement initiatives toward 5 Sigma quality standards.
Matching Summary
The primary purpose of this role is to apply intensive engineering knowledge to ensure New Product Introduction 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
Test method validation and protocol writing
Nice-to-have
Master's degree in engineering field
Six Sigma Black Belt certification
Experience mentoring engineering teams
Cross-functional project team leadership
Continuous improvement mindset
Strong written and oral communication skills
Key Requirements
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