Medical device fda/european regulatory requirements
Iso 14971 risk management
Design controls and supplier controls
Support new product development to ensure desired design performance meeting applicable medical device regulatory requirements and company policies
Job Summary
Support new product development to ensure desired design performance meeting applicable medical device regulatory requirements and company policies.
Lead Risk Management (ISO 14971) and Usability program activities, including planning, analyses (DFMEA, FTA, Risk/Benefit), 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 meeting applicable medical device regulatory requirements and company policies.
Salary
$120,450 - $176,660
Skills & Requirements
Must-have
Medical device FDA/European regulatory requirements
ISO 14971 Risk Management
Design controls and supplier controls
Design verification and validation protocols
Process validation protocols
Root cause analyses investigations
Statistical methods for product development
Nice-to-have
Collaborative team environment
Customer success focus
Innovation and better solutions
Respectful interaction
Open and honest communication
Doing the right things
Key Requirements
Bachelor's Degree in Engineering or related field
7-10 years of experience
Practical knowledge of FDA Quality System Regulations, ISO 13485, and Medical Device Directive
Proficiency in statistical methods (ANOVA, SPC, DOE)