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 the generation of test methods, validate processes using statistical tools like Minitab, and support regulatory inspections and audits.
This position requires adherence to strict safety, environmental, and quality requirements while fostering a culture of innovation, collaboration, and integrity.
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
Minitab statistical analysis software
ISO14971 risk management knowledge
FDA regulations and QMS compliance
Root cause analysis and CAPA leadership
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 methodology expertise
Key Requirements
Bachelor's degree in engineering or related field
Minimum 7 years of progressive engineering experience
Strong working knowledge of statistics and Minitab