Senior Design Assurance Engineer

486

Base: $120,450 - $176,660; bonus/equity: cash-base...
Iso 14971 risk management
Design verification and validation
Process validation protocols
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, leading cross-function teams in planning, analyses (DFMEA, FTA, Risk/Benefit) and mitigations.
  • The company offers a comprehensive benefits package with immediate eligibility including medical, dental, vision, disability, life insurance, and adoption benefits, plus 401(k) with company matching.

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

Base: $120,450 - $176,660; Bonus/Equity: cash-based incentive program; Benefits: comprehensive benefits package

Skills & Requirements

Must-have

  • ISO 14971 Risk Management
  • Design Verification and Validation
  • Process Validation Protocols
  • Supplier Risk Management
  • Root Cause Analysis
  • Statistical Methods

Nice-to-have

  • Customer success focus
  • Collaborative team environment
  • Respectful interaction
  • Open and honest communication
  • Integrity in actions

Key Requirements

  • Bachelor’s Degree in Engineering or related field
  • 7-10 years of experience
  • FDA Quality System Regulations
  • ISO 13485 and Medical Device Directive
  • ISO 14971
  • FDA and European regulated medical devices experience

Work Rights

Not specified

Tailored Resume

Cover Letter