Design Quality Engineer

Mondo
Danvers, MA

Apply now: Design Quality Engineer, Remote (Ideally Local). The start date is end of February for this 4-month contract position.

Job Title: Design Quality Engineer

Location-Type: Remote

Start Date Is: End of February

Duration: 4 months (Contract, until end of June)

Compensation Range: $55-$63/hour W2

Job Description:
Support design quality initiatives for medical device development, ensuring compliance, risk management, and documentation standards are met.

Day-to-Day Responsibilities:

  • Prepare and manage submission documentation.
  • Oversee risk management processes for pre-commercial medical devices.
  • Ensure compliance with DHF (Design History File) requirements.
  • Collaborate with engineers, providing constructive feedback and ensuring adherence to quality standards.
  • Work on medical devices, focusing on either disposables or capital equipment.

Requirements:

  • Must-Haves:

    • 4 years of experience in design quality engineering.
    • Strong experience with submission documentation and risk management.
    • Prior work in medical device quality for disposables or capital equipment.
    • DHF experience.
    • Ability to effectively push back on engineers while maintaining professional communication.
  • Nice-to-Haves:

    • Experience with client's product lines or similar high-complexity medical devices.

Soft Skills:

  • Strong communication and collaboration skills.
  • Ability to challenge engineers in a respectful and productive manner.

Posted 2025-08-29

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