Design Quality Engineer

Company Description SARACA is a global engineering R&D services company serving 25 Fortune 500 customers across MedTech, Aerospace, Rail, Automotive, Semiconductor, Defense, and Farm industries. The organization is ISO 13485 certified and specializes in the design and development of next-generation medical devices, including embedded software, UI/UX, mechanical systems, and product testing for all classes of devices. SARACA offers unique expertise in IEC 62304, EU MDR, Clinical Evaluation Reports, Performance Evaluation Reports, and a wide range of scientific writing in MedTech. With a technically proficient team of 400 engineers and management consultants, the company delivers solutions to complex business problems through onsite and offsite projects worldwide. SARACA is an equal-opportunity employer that promotes a culture of innovation and learning, focused on helping customers grow faster and lead their industries.

ole: Design Quality Engineer (DQE)

Work location: Andover, MA

Background and Meet and Greet: MANDATORY

Job Description:

• Working from client office: Yes (Hybrid 3 days per week).
• 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

At Capgemini Engineering, the world leader in engineering services, we bring together a global team of engineers, scientists, and architects to help the world's most innovative companies unleash their potential. From autonomous cars to life-saving robots, our digital and software technology experts think outside the box as they provide unique R&D and engineering services across all industries. Join us for a career full of opportunities. Where you can make a difference. Where no two days are the same.

As a 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)

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

Capgemini is a global business and technology transformation partner, helping organizations to accelerate their dual transition to a digital and sustainable world, while creating tangible impact for enterprises and society. It is a responsible and diverse group of 340,000 team members in more than 50 countries. With its strong over 55-year heritage, Capgemini is trusted by its clients to unlock the value of technology to address the entire breadth of their business needs. It delivers end-to-end services and solutions leveraging strengths from strategy and design to engineering, all fueled by its market leading capabilities in AI, generative AI, cloud and data, combined with its deep industry expertise and partner ecosystem.