$120,450 - $176,660; not specified; not specified ...
Iso 14971 risk management
Fda quality system regulations
Iso 13485
Support new product development to ensure desired design performance meets applicable medical device regulatory requirements and company policies
Job Summary
Support new product development to ensure desired design performance meets applicable medical device regulatory requirements and company policies.
Lead Risk Management and Usability program activities, including planning, analyses, and mitigations, maintaining the risk management file for the life of the device.
The total rewards program includes base salary, cash-based incentive program, comprehensive benefits with immediate eligibility, 401(k) with company match, 80 hours of holidays, and paid time off.
Matching Summary
Support new product development to ensure desired design performance meets applicable medical device regulatory requirements and company policies.
Salary
$120,450 - $176,660; Not specified; Not specified
Skills & Requirements
Must-have
ISO 14971 Risk Management
FDA Quality System Regulations
ISO 13485
Medical Device Directive
Design Verification and Validation
Statistical Methods
Nice-to-have
Collaboration and conflict resolution
Coaching and team leadership
Lean Sigma tools proficiency
Sterilization process knowledge
Key Requirements
7-10 years of experience
Bachelor's Degree in Engineering
Master's Degree preferred
Experience with FDA and European regulated medical devices preferred