Senior Design Quality Engineer

Capgemini; Andover (MA); On-site; USD 61,000 - 95,000; Full time

Job summary

Capgemini is seeking a Senior Design Quality Engineer (Contract) to lead product development quality activities for regulated medical devices in the Greater Boston area. You will drive design controls, risk management, and software SDLC compliance across the lifecycle from concept to post-market, collaborating with cross-functional teams to ensure audit-ready documentation.

The role requires extensive experience in quality engineering for Class II/III devices, familiarity with standards like 21

Qualifications

• 10+ years of experience in Quality Engineering supporting regulated medical device development (Class II/III preferred)
• Strong hands-on experience with design controls, DHF management, and traceability in regulated environments
• Working knowledge of applicable standards and regulations (e.g., 21 CFR 820, ISO 13485, ISO 14971, IEC 62304)
• Experience supporting software quality within the SDLC and understanding of software risk management principles
• Proven experience with risk management tools (e.g., FMEA, hazard analysis) and integration into product development
• Experience supporting audits and regulatory submissions, with the ability to defend design and quality documentation
• Strong analytical, documentation, and communication skills with ability to work effectively across cross-functional teams
• Experience with quality systems, eQMS/PLM tools, and defect/CAPA management processes

Responsibilities

• Serving as the quality lead 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)

Job description

Senior Design Quality Engineer (Contract)

Andover, MA, United States (On-site)

Contract (3 months 17 days)

Published 6 days ago

root cause analysis

Quality Management Systems

Quality Documentation

regulatory compliance

cross - functional collaboration

quality engineering

As a Senior Design Quality Engineer (DQE) for our medical device manufacturer client in the Greater Boston region, you will be responsible for ensuring end to end design quality and compliance across the product development lifecycle for Class II/III medical devices, including software-driven and active implantable products. Working directly with cross-functional teams, you will drive adherence to design controls, risk management, and SDLC best practices from concept through commercialization and post market activities.

Key Responsibilities

In this role you will play a key role in:

Serving as the quality lead 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)

Qualifications:

Bachelor’s degree in Engineering (Biomedical, Software, Systems) or a related technical discipline

Advanced degree (Master’s) in Engineering, Quality, or Regulatory Affairs preferred

Relevant certifications (e.g., ASQ CQE, CSQE, Six Sigma Green/Black Belt) are a plus

Required Skills:

10+ years of experience in Quality Engineering supporting regulated medical device development (Class II/III preferred)

Strong hands‑on experience with design controls, DHF management, and traceability in regulated environments

Working knowledge of applicable standards and regulations (e.g., 21 CFR 820, ISO 13485, ISO 14971, IEC 62304)

Experience supporting software quality within the SDLC and understanding of software risk management principles

Proven experience with risk management tools (e.g., FMEA, hazard analysis) and integration into product development

Experience supporting audits and regulatory submissions, with the ability to defend design and quality documentation

Strong analytical, documentation, and communication skills with ability to work effectively across cross‑functional teams

Experience with quality systems, eQMS/PLM tools, and defect/CAPA management processes

The pay range that the employer in good faith reasonably expects to pay for this position is $43.92/hour - $68.62/hour. Our benefits include medical, dental, vision and retirement benefits. Applications will be accepted on an ongoing basis.

We are an equal opportunity employer, and we do not discriminate on the basis of race, religion, color, national origin, sex, sexual orientation, age, veteran status, disability, genetic information, or other applicable legally protected characteristic. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law, including the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. Unincorporated LA County workers: we reasonably believe that criminal history may have a direct, adverse and negative relationship with the following job duties, potentially resulting in the withdrawal of a conditional offer of employment: client provided property, including hardware (both of which may include data) entrusted to you from theft, loss or damage; return all portable client computer hardware in your possession (including the data contained therein) upon completion of the assignment, and; maintain the confidentiality of client proprietary, confidential, or non‑public information. In addition, job duties require access to secure and protected client information technology systems and related data security obligations.