Support new product development to ensure desired design performance meets applicable medical device regulatory requirements
Job Summary
Support new product development to ensure desired design performance meets applicable medical device regulatory requirements.
Lead Risk Management (ISO 14971) and Usability program activities, including planning, analyses, and mitigations.
The company offers a comprehensive benefits package with immediate eligibility, including medical, dental, vision, and a 401(k) plan with company matching.
Matching Summary
Support new product development to ensure desired design performance meets applicable medical device regulatory requirements.
Salary
$120,450 - $176,660
Skills & Requirements
Must-have
Medical device regulatory requirements
ISO 14971 Risk Management
Design controls
Supplier risk management
Statistical methods
Nice-to-have
Customer success focus
Innovation and collaboration
Respectful interaction
Open and honest communication
Integrity in actions
Key Requirements
Bachelor’s Degree in Engineering or related field
7-10 years of experience
Practical knowledge of FDA QSR, ISO 13485, Medical Device Directive
Proficiency in statistical methods (ANOVA, SPC, DOE)