Senior Design Quality Engineer

Company DescriptionSARACA is a global engineering R&D services company serving 25+ Fortune 500 customers across diverse industries, including MedTech, Aerospace, Rail, Automotive, and Defense. Certified in ISO 13485, SARACA specializes in the design and development of innovative medical devices, providing expertise in embedded software, UI/UX design, mechanical systems, and product testing. With a team of 400+ engineers and management consultants, SARACA excels in delivering solutions for complex business problems and complying with global regulations like IEC 62304 and EU MDR. The company fosters a culture of innovation and learning, supporting the growth and leadership of its customers and employees alike.Senior Design Quality EngineerWork location: Andover, MABackground and Meet and Greet: MANDATORYJob Description:"Senior Design Quality Engineer· No. of Positions: 1· Grade: C2=? 10-12 years· Location: Andover, MA· Working from client office: Yes (Hybrid 3 days per week).· Qualifications:o Bachelor’s degree in Engineering (Biomedical, Software, Systems) or a related technical disciplineo Advanced degree (Master’s) in Engineering, Quality, or Regulatory Affairs preferredo Relevant certifications (e.g., ASQ CQE, CSQE, Six Sigma Green/Black Belt) are a plusAt 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.Job DescriptionAs 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 ResponsibilitiesIn 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 processesCapgemini 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, gene"What are the Mandatory skills and skill proficiencies required for this position?"• 10+ years of experience in software quality assurance within regulated environments (medical device preferred)• Experience supporting IDE, PMA, or similar regulatory pathways with understanding of clinical evidence requirements• Strong understanding of SDLC and design controls in regulated environments (e.g., traceability, DHF)• Proven experience reviewing and improving SOPs or quality processes for regulatory compliance• Hands on experience with software verification and validation using risk based approaches aligned with FDA expectations• Familiarity with FDA regulations and standards (e.g., 21 CFR 820, 812, 814)• Experience with test management, defect tracking, and quality documentation tools• Strong analytical, documentation, and stakeholder communication skills with ability to influence quality decisions"