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 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, parental leave, and 401(k) 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; Bonus/Equity: Cash-based incentive program; Benefits: Medical, dental, vision, disability, life insurance, adoption benefits, parental leave, 401(k) with company match, 80 hours holidays, paid time off
Skills & Requirements
Must-have
ISO 14971 Risk Management
Design Controls
FDA Quality System Regulations
ISO 13485
Medical Device Directive
Statistical Methods
Root Cause Analysis
Nice-to-have
Collaboration and conflict resolution
Team leadership and coaching
Open and honest communication
Respectful interaction
Customer success focus
Key Requirements
Bachelor's Degree in Engineering or related field
7-10 years of experience
Master's Degree preferred
Experience with FDA and European regulated medical devices preferred