This role involves applying intensive engineering knowledge to ensure New Product Introduction projects result in high-quality products for medical device OEMs
Job Summary
This role involves applying intensive engineering knowledge to ensure New Product Introduction projects result in high-quality products for medical device OEMs.
The engineer will lead testing and validation of new test methods, including gage R&R studies and statistical analysis using Minitab.
Candidates must adhere to strict Quality Management Systems, FDA regulations, and support regulatory inspections and audits.
Matching Summary
This role involves applying intensive engineering knowledge to ensure New Product Introduction 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
Root cause analysis and CAPA leadership
Process validation and capability studies
Nice-to-have
Master's degree in engineering
Six Sigma Black Belt certification
Cross-functional team leadership
Supplier quality collaboration
Continuous improvement mindset
5 Sigma journey participation
Key Requirements
Bachelor's degree in engineering or related field
7+ years of progressive engineering experience
Six Sigma Green Belt minimum (Black Belt preferred)