Design Quality Engineer

ZipRecruiter; Danvers (MA); Remote; USD 100,000 - 125,000; Full time

Job summary

A leading company in the medical device sector is looking for a Design Quality Engineer for a remote contract role lasting 4 months, starting at the end of February. The role involves ensuring compliance and risk management for medical device development, with responsibilities including submission documentation preparation and collaboration with engineering teams. Ideal candidates will have extensive experience in design quality engineering, particularly in medical devices.

Qualifications

• 4 years of experience in design quality engineering.
• Strong experience with risk management and submission documentation.
• Prior work in medical device quality for disposables or capital equipment.

Responsibilities

• Prepare and manage submission documentation.
• Oversee risk management processes for pre-commercial medical devices.
• Collaborate with engineers to ensure adherence to quality standards.

Skills

Communication

Collaboration

Job description

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.