The primary purpose of this role is to apply intensive engineering knowledge to ensure New Product Introduction projects result in high-quality products
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.
Candidates will lead testing and validation of new test methods, including gage R&R studies and statistical analysis using software like Minitab.
This position requires adherence to strict Quality Management Systems, FDA regulations, and ISO standards while supporting regulatory inspections and audits.
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.
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
Nice-to-have
Master's degree in engineering
Six Sigma Black Belt certification
Experience mentoring engineering teams
Cross-functional project leadership
Continuous improvement mindset
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 domestic and international regulations (ISO, QSR, UL)