Senior Design Quality Engineer - Medical Devices (Hybrid)

Capgemini; New Jersey; Hybrid; USD 69,000 - 150,000; Full time

Job summary

Capgemini Engineering, a world‑leading engineering services firm, seeks a Senior Design Quality Engineer for medical devices. You will drive end‑to‑end design quality across lifecycle, ensuring compliance with design controls, risk management, and SDLC best practices for Class II/III medical devices, including software‑driven products. You’ll collaborate with cross‑functional teams to uphold regulatory readiness and audit success.

Qualifications

• Bachelor's degree in engineering or related field; regulated industries preferred.
• 10+ years in software quality assurance within regulated environments.
• Experience with IDE, PMA, or similar regulatory pathways.
• Strong understanding of SDLC and design controls (traceability).
• Hands-on software verification and validation using risk-based approaches.
• Familiarity with FDA regulations (21 CFR 820/812/814).

Responsibilities

• Serve as Senior Design Quality Engineer on product teams, ensuring design controls across lifecycle.
• Establish and maintain DHF, DMR, and DHR with traceability from needs to verification/validation.
• Lead risk management activities and integrate risk controls into design/validation.
• Provide quality oversight of software SDLC activities per standards (IEC 62304).
• Review and approve design, software, and validation deliverables for audit readiness.
• Support verification, validation, and design transfer activities aligning design outputs to production.

Skills

Quality assurance

Risk management

SDLC knowledge

Regulatory compliance

Stakeholder communication

Analytical skills

Software verification

Audit readiness

Education

Bachelor's degree in engineering

Business or CS background

Tools

SOPs improvement

Test management

Defect tracking

Quality documentation tools

Job description

Capgemini Engineering, a world‑leading engineering services firm, seeks a Senior Design Quality Engineer for medical devices. You will drive end‑to‑end design quality across lifecycle, ensuring compliance with design controls, risk management, and SDLC best practices for Class II/III medical devices, including software‑driven products. You’ll collaborate with cross‑functional teams to uphold regulatory readiness and audit success.