Design Quality Engineer

Job DescriptionJob Description

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.