Product Design Quality Engineer

Job overview

The Product Design Quality Engineer role is onsite in Cambridge, MA. Compensation is not specified. The position supports product development and manufacturing transfer through quality and regulatory compliance activities. The role integrates quality into the product lifecycle by supporting design controls, risk management, verification and validation, and manufacturing readiness. It helps ensure design records, changes, and processes meet applicable medical-device requirements and quality standards.

What you'll do

• Support design control activities, design planning, design reviews, verification and validation, and review of design documentation.
• Maintain design traceability records, including DHF and DMR documentation.
• Review engineering changes, support risk analyses and design transfer, and participate in audits, CAPA investigations, and QMS improvements.

What we're looking for

Skills & competencies

product design quality engineer

cambridge ma

katalyst healthcares & life sciences

medical devices

design controls

design assurance

verification and validation

risk management

design transfer

fda-regulated

iso 13485

iso 14971

Work arrangement

• Weekend coverage required

Why this role

Medical-device design quality work involving FDA requirements, ISO 13485, ISO 14971, and design transfer.

About the employer

Katalyst Healthcares & Life Sciences is hiring for this role. Industry: Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology). Sector: 54.