Welcome to Jobsnearme.fresherhiring.in We provide job seekers with information gathered from various publicly available job posting websites, including but not limited to Google, Indeed, LinkedIn, and other well-known job platforms. Our mission is to help individuals find employment opportunities by offering up-to-date job listings and career-related resources. We do not charge any fees for accessing or using our website, and all job information is provided free of charge.
Jobsnearme.fresherhiring.in does not directly offer, manage, or engage in the hiring process for any of the job listings featured on our website. All listings are sourced from third-party job posting platforms such as Indeed, LinkedIn, and other recognized job websites.
By using our website, you acknowledge and accept the above terms and conditions. Thank you for visiting Jobsnearme.fresherhiring.in, and we wish you success in your job search.
Note: The job is a remote job and is open to candidates in USA. Capgemini Engineering provides engineering, software, and research and development services across industries. The Senior Design Quality Engineer will ensure end-to-end design quality and regulatory compliance for Class II/III medical devices, overseeing design controls, risk management, software development lifecycle activities, verification, validation, audits, and post-market processes.
Responsibilities
Serving as the Senior Design Quality Engineer on product development teams, ensuring compliance with design controls(specifically software) 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
Responsible for 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
Responsible for 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)
Skills
Bachelor's degree in business, Engineering, Project Management, Computer Science, or a related discipline
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
Should have embedded development/ Digital Platform background Or exposure to embedded development / Digital Platform within Medical Devices domain (preference class II OR III)
Benefits
Hybrid work arrangement (minimum 3 days onsite) – Andover, MA OR Remote
Paid time off based on employee grade (A-F), defined by policy: Vacation: 12-25 days, depending on grade, Company paid holidays, Personal Days, Sick Leave
Medical, dental, and vision coverage (or provincial healthcare coordination in Canada)
Retirement savings plans (e.g., 401(k) in the U.S., RRSP in Canada)
Life and disability insurance
Employee assistance programs
This role may be eligible for additional compensation such as variable incentives, bonuses, or commissions, depending on the position and applicable laws
Company Overview
Capgemini is a software company that provides consulting, technology, and digital transformation services. It was founded in 1967, and is headquartered in Paris, Ile-de-France, FRA, with a workforce of 10001+ employees. Its website is https://www.capgemini.com.
Company H1B Sponsorship
Capgemini has a track record of offering H1B sponsorships, with 1042 in 2026, 2788 in 2025, 2969 in 2024, 3415 in 2023, 4386 in 2022, 3311 in 2021, 5871 in 2020. Please note that this does not guarantee sponsorship for this specific role.
