Medical Device Quality Engineer: Risk & Design Controls

Katalyst-Healthcares-; Danvers (MA); On-site; USD 90,000 - 130,000; Full time

Job summary

We are seeking an experienced Quality Engineer to support risk management, design controls, and product lifecycle activities for Class II and/or Class III medical devices. The candidate will develop, review, and maintain risk management documentation in accordance with ISO 14971, supporting DFMEA and PFMEA activities, and ensuring compliance with medical device quality and regulatory requirements.

This role will also support remediation initiatives, DHF updates, and audit readiness in

Qualifications

• Bachelor's degree in engineering or related technical field.
• 5–10 years of medical device experience.
• Experience with ISO 14971 risk management processes.
• Experience with DFMEA, PFMEA, hazard analysis and risk assessment methodologies.
• Experience supporting design controls and maintaining DHF documentation.
• Experience with Class II and/or Class III medical devices.

Responsibilities

• Develop, review, and maintain product risk management documentation per ISO 14971.
• Participate in DFMEA and PFMEA activities.
• Update risk management files, hazard analyses, and risk assessments.
• Perform risk assessments related to design modifications and lifecycle activities.
• Maintain traceability between requirements, risks, controls, and verification/validation.

Skills

Risk management

DFMEA

PFMEA

ISO 14971

Design controls

DHF

Regulatory compliance

Education

Bachelor's degree in engineering

Job description

We are seeking an experienced Quality Engineer to support risk management, design controls, and product lifecycle activities for Class II and/or Class III medical devices. The candidate will develop, review, and maintain risk management documentation in accordance with ISO 14971, supporting DFMEA and PFMEA activities, and ensuring compliance with medical device quality and regulatory requirements.

This role will also support remediation initiatives, DHF updates, and audit readiness in