$120,450 - $176,660; not specified; not specified ...
Iso 13485
Fda quality system regulations
Medical device directive
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 company provides a comprehensive benefits package with immediate eligibility including medical, dental, vision, disability, life insurance, and adoption benefits.
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; Not specified; Not specified
Skills & Requirements
Must-have
ISO 13485
FDA Quality System Regulations
Medical Device Directive
ISO 14971
Risk Management
Design Controls
Process Validation
Nice-to-have
Collaboration
Inclusion
Integrity
Customer focus
Lean Sigma tools
Key Requirements
Bachelor’s Degree in Engineering or related field
7-10 years of experience
Experience with FDA and European regulated medical devices