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Senior Design Assurance Quality Engineer

Biomedical Search

Billerica, MA

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JOB DETAILS
SKILLS
Biology, Catheterization, Code of Federal Regulations, Communication Skills, Cross-Functional, Data Analysis, Documentation, Electromechanics, FDA (Food and Drug Administration), Failure Mode and Effects Analysis (FMEA), Hazard Analysis, ISO (International Organization for Standardization), International Electro-Technical Commission (IEC), Maintain Compliance, Manufacturing, Manufacturing Requirements, Medical Equipment, Product Design, Product Development, Product Support, Quality Assurance, Quality Engineering, Quality Management, Regulatory Submissions, Research & Development (R&D), Risk Analysis, Risk Management, Software Administration, Software Design, Statistics, Time Management, Validation Testing
LOCATION
Billerica, MA
POSTED
30+ days ago
We are partnering with a growing medical device company seeking a Senior Design Assurance Quality Engineer to support product development from concept through launch.This is a highly visible, cross-functional role working closely with R&D, Quality, Regulatory, and Manufacturing teams to ensure products are developed in compliance with FDA and ISO standards—while maintaining a strong focus on quality, risk management, and timely product delivery.What You’ll Be Doing
  • Lead and support Design Assurance activities across product development programs
  • Ensure compliance with Design Controls and Risk Management requirements
  • Drive Verification & Validation (V&V) planning, execution, and documentation
  • Partner with cross-functional teams to ensure quality is built into product design
  • Support risk management activities (FMEAs, hazard analysis, risk assessments)
  • Contribute to design transfer and manufacturing readiness
  • Maintain clear and compliant design documentation for regulatory submissions
  • Support post-market activities, including investigations and data analysis
  • Support software quality activities aligned with IEC 62304
What We’re Looking For
  • Bachelor’s degree in Engineering or related technical field
  • 5–8+ years of experience in Design Assurance / Quality Engineering within medical devices or life sciences
  • Strong knowledge of:
    • FDA 21 CFR 820
    • ISO 13485 and ISO 14971
  • Hands-on experience with:
    • Design Controls
    • Verification & Validation (V&V)
    • Risk Management (FMEA, hazard analysis)
  • Experience supporting new product development and design transfer
  • Strong communication skills and ability to work cross-functionally
Nice to Have:
  • Experience with software design assurance (IEC 62304)
  • Familiarity with complex devices (electromechanical, catheter-based, etc.)
  • Experience with statistical tools or data analysis

About the Company

B

Biomedical Search

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