Senior Design Quality Engineer - Medical Devices (Software)

Capgemini; Andover (MA); Híbrido; USD 69 000 - 150 000; Tempo integral

Resumo da oferta

Capgemini Engineering seeks a Senior Design Quality Engineer for medical devices in the Andover, MA area. You will ensure end-to-end design quality and regulatory compliance across the product lifecycle for Class II/III devices, including software-driven products, working with cross-functional teams.

The role focuses on design controls, risk management (FMEA), and software SDLC alignment (IEC 62304). You will lead or support CAPA, audits (FDA/ISO), and regulatory submissions, with

Responsabilidades

• Serve as the Senior Design Quality Engineer on product development teams, ensuring compliance with design controls across all lifecycle phases (planning, inputs/outputs, verification, validation, transfer, and change management)
• Establishing and maintaining DHF, DMR, and DHR, ensuring complete traceability from user needs through verification and validation evidence
• Leading and maintaining risk management activities (hazard analysis, FMEA, risk files) and ensuring integration of risk controls into design and validation activities
• Providing quality oversight of software SDLC activities, ensuring compliance with applicable standards (e.g., IEC 62304) and integration with system-level risk management
• Reviewing and approving design, software, and validation deliverables to ensure completeness, consistency, and audit readiness
• Supporting verification, validation, and design transfer activities, ensuring alignment between design outputs and production processes
• Leading or supporting CAPA, nonconformance investigations, and root cause analysis to drive continuous improvement
• Supporting internal and external audits (FDA, Notified Body, ISO), and contributing to regulatory submissions (e.g., IDE, PMA, EU MDR)

Conhecimentos

Software quality assurance

Regulated environments

Embedded development

SDLC / design controls

Test management

Formação académica

Bachelor's degree in engineering or related field

Ferramentas

FMEA

Regulatory documentation tools

Descrição da oferta de emprego

Capgemini Engineering seeks a Senior Design Quality Engineer for medical devices in the Andover, MA area. You will ensure end-to-end design quality and regulatory compliance across the product lifecycle for Class II/III devices, including software-driven products, working with cross-functional teams.

The role focuses on design controls, risk management (FMEA), and software SDLC alignment (IEC 62304). You will lead or support CAPA, audits (FDA/ISO), and regulatory submissions, with