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 ensuring compliance with FDA regulations and Quality Management Systems.
This position requires a subject matter expert with 7+ years of experience who can independently resolve complex problems and mentor other engineers within a global organization.
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
7+ years progressive engineering experience
Bachelor's degree in engineering field
Statistical analysis using Minitab software
ISO14971 risk management support
FDA regulations and QMS adherence
Root cause analysis and CAPA leadership
Test method validation and gage R&R
Nice-to-have
Master's degree in engineering preferred
Six Sigma Black Belt certification
Mentoring and coaching engineering teams
Cross-functional project team leadership
Continuous improvement culture mindset
Supplier quality capability studies
5 Sigma journey participation
Key Requirements
Bachelor's degree in engineering or related field
Minimum 7 years of progressive engineering experience
Strong working knowledge of Statistics and Minitab
Awareness of ISO, QSR, UL, MDD, TGA standards
Green Belt Six Sigma minimum; Black Belt preferred