Design Quality Engineer

Job overview

The Design Quality Engineer role is onsite in Boston, MA. Compensation is not specified. The role supports Philips product design and development by embedding quality into product design in collaboration with research and development, regulatory, manufacturing, and suppliers. The engineer helps ensure medical device designs meet regulatory, quality, and customer requirements throughout the product lifecycle. Design controls, risk management, quality-system support, and manufacturing transfer readiness contribute to compliant product development and successful project milestones.

What you'll do

• Ensure design control compliance with 21 CFR Part 820 and ISO 13485
• participate in design planning, reviews, and verification and validation
• review and approve design inputs, outputs, and technical documentation
• maintain design history, device master, and device history records and traceability
• review engineering change requests and orders
• support design transfer to manufacturing
• guide lifecycle risk management, FMEA, and hazard analysis
• support audits and inspections
• manage CAPA, root cause analysis, and corrective solutions
• contribute to quality management system processes.

What we're looking for

Skills & competencies

design quality engineer

onsite

boston ma

katalyst healthcares & life sciences

philips

medical devices

design controls

21 cfr part 820

iso 13485

risk management

fmea

capa

design verification

design validation

Work arrangement

• Weekend coverage required

Why this role

Requires a bachelor's degree or equivalent and at least five years of experience in FDA-regulated medical device environments, with a focus on design assurance/control and risk.

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.