Senior Design Quality Engineer, Medical Devices (Software)

JobDiva, Inc.; Andover (MA); On-site; USD 120,000 - 150,000; Full time

Job summary

JobDiva, Inc. is seeking a Senior Design Quality Engineer in the Greater Boston area to drive end-to-end design quality for Class II/III medical devices across the product lifecycle.

You will ensure design controls, risk management, and SDLC best practices from concept through commercialization and post-market activities. Responsibilities include leading design controls, maintaining DHF/DMR/DHR, and overseeing risk management, software V&V, and regulatory submissions with cross-functional teams.

Qualifications

• Mandatory experience supporting software quality within the SDLC and understanding of software risk management principles.
• Experience participating in software design reviews, software architecture reviews, and assessment of software lifecycle deliverables.
• 10+ years' experience in FDA regulated, IEC 62304 medical device software environments.

Responsibilities

• Serve as Senior Design Quality Engineer on product development teams, ensuring compliance with design controls for software across lifecycle phases.
• Establish and maintain DHF, DMR, DHR with complete traceability from user needs through verification and validation.
• Lead risk management activities (hazard analysis, FMEA, risk files) and integrate risk controls into design and validation.
• Provide quality oversight of software SDLC activities, ensuring IEC 62304 compliance and integration with system risk management.
• Review and approve design, software, and validation deliverables for audit readiness.
• Support CAPA, nonconformance investigations, root cause analysis, and continuous improvement.
• Support audits and regulatory submissions (FDA, Notified Body, ISO) and defend software quality documentation.

Skills

Design quality

Software risk management

Root cause analysis

SDLC

Agile / SAFe

Education

Bachelor's degree in a related field

Master's degree preferred

Tools

C/C++/C#

IEC 62304

ISO 14971

Job description

JobDiva, Inc. is seeking a Senior Design Quality Engineer in the Greater Boston area to drive end-to-end design quality for Class II/III medical devices across the product lifecycle.

You will ensure design controls, risk management, and SDLC best practices from concept through commercialization and post-market activities. Responsibilities include leading design controls, maintaining DHF/DMR/DHR, and overseeing risk management, software V&V, and regulatory submissions with cross-functional teams.