The primary purpose of this job is to support new product development to ensure that the desired design performance is achieved meeting the applicable medical device FDA/European regulatory requirements and companies Policies & Procedures
Job Summary
The primary purpose of this job is to support new product development to ensure that the desired design performance is achieved meeting the applicable medical device FDA/European regulatory requirements and companies Policies & Procedures.
Leads Risk Management (ISO 14971) and Usability program activities. Leads cross function teams in planning, analyses (DFMEA, FTA, Risk/Benefit) and mitigations.
We provide a comprehensive benefits package with immediate eligibility including medical, dental, vision, disability, life insurance, and adoption benefits.
Matching Summary
The primary purpose of this job is to support new product development to ensure that the desired design performance is achieved meeting the applicable medical device FDA/European regulatory requirements and companies Policies & Procedures.
Salary
$120,450 - $176,660
Skills & Requirements
Must-have
ISO 14971 Risk Management
Design Verification and Validation
Process Validation Protocols
Supplier Risk Management
Statistical Methods Proficiency
Quality Lean Sigma Tools
Nice-to-have
Collaboration and Negotiation Skills
Team Leadership and Coaching
Cross-functional Guidance
Key Requirements
Bachelor’s Degree in Engineering or related field
7-10 years of experience
Practical knowledge of FDA Quality System Regulations, ISO 13485 and Medical Device Directive
Experience interpreting design schematics and design drawings