The primary purpose of this role is to apply intensive engineering knowledge to ensure NPI 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 NPI 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 all 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 NPI 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
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 field
Six Sigma Black Belt certification
Mentoring and coaching engineering teams
Cross-functional project team leadership
Continuous improvement culture mindset
Experience with supplier quality resolution
Key Requirements
Minimum Bachelor's degree in engineering
7+ years of relevant engineering experience
Strong working knowledge of Statistics
Awareness of Domestic and International Regulations