$120,450 - $176,660; not specified; not specified ...
Medical device fda/european regulatory requirements
Quality management systems (qms)
Iso 14971 risk management
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 (ISO 14971) 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; Not specified; Not specified
Skills & Requirements
Must-have
Medical device FDA/European regulatory requirements
Quality Management Systems (QMS)
ISO 14971 Risk Management
Design verification and validation
Process validation protocols
Supplier risk management
Statistical methods
Nice-to-have
Customer success focus
Innovation and collaboration
Respectful interaction
Open and honest communication
Integrity in actions
Key Requirements
Bachelor’s Degree in Engineering or related field
7-10 years of experience
Practical knowledge of FDA Quality System Regulations, ISO 13485, Medical Device Directive
Practical knowledge of ISO 14971
Experience interpreting design schematics and drawings
Proficiency in statistical methods (ANOVA, SPC, DOE)