Senior Design Quality Engineer – Medical Devices

Katalyst CRO; Andover (MA); On-site; USD 100,000 - 130,000; Full time

Job summary

Katalyst CRO is seeking a Senior Design Quality Engineer to ensure design quality compliance for medical devices in the Greater Boston area. The role requires leadership on product development teams, ensuring adherence to design controls and risk management throughout the product lifecycle.

The ideal candidate will have over 10 years of relevant experience, extensive knowledge of applicable standards, and the ability to work cross-functionally while supporting audits and regulatory submissions.

Qualifications

• 10+ years of experience in Quality Engineering supporting regulated medical device development.
• Strong hands-on experience with design controls and DHF management.
• Proven experience with risk management tools and integration into product development.

Responsibilities

• Ensure compliance with design controls across all lifecycle phases.
• Lead and maintain risk management activities.
• Support internal and external audits and regulatory submissions.

Skills

Design controls

DHF management

Risk management

Software SDLC

FMEA

Quality documentation

Regulatory compliance

Education

Bachelor's degree in Engineering

Advanced degree in Engineering, Quality, or Regulatory Affairs

Relevant certifications (e.g., ASQ CQE, CSQE)

Tools

eQMS/PLM tools

Defect tracking tools

Job description

Katalyst CRO is seeking a Senior Design Quality Engineer to ensure design quality compliance for medical devices in the Greater Boston area. The role requires leadership on product development teams, ensuring adherence to design controls and risk management throughout the product lifecycle.

The ideal candidate will have over 10 years of relevant experience, extensive knowledge of applicable standards, and the ability to work cross-functionally while supporting audits and regulatory submissions.