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 (DFMEA, FTA, Risk/Benefit), and mitigations.
The total rewards program includes base salary, cash-based incentive program, comprehensive benefits with immediate eligibility, 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
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
Coaching abilities
Cross-functional team leadership
Medical device sterilization process knowledge
Key Requirements
Bachelor's Degree in Engineering or related field
7-10 years of experience
Experience with FDA and European regulated medical devices preferred