Senior Medical Device Software Quality Engineer

Capgemini Engineering; Burlington (VT); Hybrid; USD 69,000 - 150,000; Full time

Benefits offered by this job

Vacation/Leave benefits

Medical, dental, vision

Retirement savings plans

Life and disability insurance

Job summary

Capgemini Engineering is seeking a Senior Design Quality Engineer for Medical Devices to ensure end-to-end design quality and compliance across the product lifecycle for Class II/III devices, including software-driven and active implantable products.

You will drive design controls, risk management, and SDLC best practices with cross-functional teams, supporting regulatory submissions and audits (FDA, ISO, EU MDR) throughout development and post-market activities.

Qualifications

• Bachelor's degree in Software Engineering, Computer Engineering, Systems Engineering, Biomedical Engineering, Electrical Engineering, or related technical discipline.
• 10+ years' experience in FDA-regulated, IEC 62304 medical device software environments with emphasis on Software Design Assurance/Control, ISO 14971 risk management, SDLC, and QMS for software design controls.

Responsibilities

• Serve as the Senior Design Quality Engineer on product teams, ensuring software design controls across lifecycle phases (planning, inputs/outputs, verification, validation, transfer, change management).
• Maintain DHF, DMR, DHR with complete traceability from user needs to verification/validation evidence.
• Lead risk management activities (hazard analysis, FMEA, risk files) and integrate risk controls into design and validation.

Skills

Design quality

FDA regulatory

SDLC

Risk management

Software design

Root cause analysis

Software V&V

Traceability

Education

Bachelor's degree

Tools

IEC 62304

V&V tools

Job description

Capgemini Engineering is seeking a Senior Design Quality Engineer for Medical Devices to ensure end-to-end design quality and compliance across the product lifecycle for Class II/III devices, including software-driven and active implantable products.

You will drive design controls, risk management, and SDLC best practices with cross-functional teams, supporting regulatory submissions and audits (FDA, ISO, EU MDR) throughout development and post-market activities.