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 of new test methods, including gage R&R studies and statistical analysis using software packages like Minitab.
The successful candidate must adhere to strict safety, environmental, security, and quality requirements including FDA regulations and ISO standards while supporting regulatory inspections.
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 with Minitab
ISO14971 risk management knowledge
Root cause analysis and CAPA leadership
FDA regulations and QMS compliance
Nice-to-have
Master's degree in engineering field
Six Sigma Black Belt certification
Experience mentoring engineering teams
Cross-functional project leadership skills
5 Sigma continuous improvement mindset
Key Requirements
Minimum Bachelor's degree in engineering or related field
7+ years of progressive engineering experience
Strong working knowledge of Statistics and Minitab
Awareness of Domestic and International Regulations (ISO, QSR, UL)