Design Quality Engineer — Medical Devices

Job overview

The Design Quality Engineer role is an onsite position in Andover, MA. Compensation is not specified. The engineer supports product development for a medical device manufacturer client in the Greater Boston region, covering Class II/III devices, including software-driven and active implantable products. The role provides quality leadership across the product development lifecycle, helping teams meet design-control, risk-management, and software lifecycle requirements from concept through commercialization and post-market activities. Its work supports compliant, traceable product development and readiness for audits and regulatory submissions.

What you'll do

• Lead quality oversight of design controls across planning, inputs and outputs, verification, validation, transfer, and change management
• establish and maintain DHF, DMR, and DHR records and traceability
• lead and maintain risk-management activities including hazard analysis, FMEA, and risk files
• oversee software SDLC quality
• review and approve design, software, and validation deliverables
• support verification, validation, and design transfer
• lead or support CAPA, nonconformance investigations, and root-cause analysis
• support audits and regulatory submissions.

What we're looking for

Skills & competencies

design quality engineer

medical devices

class ii/iii

design controls

risk management

software quality

sdlc

dhf

fmea

capa

andover ma

katalyst healthcares & life sciences

audit readiness

regulatory submissions

Work arrangement

• Weekend coverage required

Why this role

Class II/III medical device development; software-driven and active implantable products; quality oversight spanning design controls, risk management, and software lifecycle activities.

About the employer

Katalyst Healthcares & Life Sciences is hiring for this role. Industry: Engineering Services. Sector: 54.