$120,450 - $176,660; not specified; not specified ...
Iso 14971 risk management
Design verification and validation
Fda quality system regulations
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 (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 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
Design Verification and Validation
FDA Quality System Regulations
ISO 13485
Medical Device Directive
Statistical Methods
Lean Sigma Tools
Nice-to-have
Collaboration and negotiation skills
Coaching and leadership ability
Cross-functional team leadership
Supplier risk management initiatives
Key Requirements
Bachelor’s Degree in Engineering or related field
7-10 years of experience
Experience with FDA and European regulated medical devices preferred