Sr. Software Developer Quality Engineer- Medical Devices

Capgemini; New Jersey; Hybrid; USD 69,000 - 150,000; Full time

Job summary

Capgemini Engineering, a world‑leading engineering services firm, seeks a Senior Design Quality Engineer for medical devices. You will drive end‑to‑end design quality across lifecycle, ensuring compliance with design controls, risk management, and SDLC best practices for Class II/III medical devices, including software‑driven products. You’ll collaborate with cross‑functional teams to uphold regulatory readiness and audit success.

Qualifications

• Bachelor's degree in engineering or related field; regulated industries preferred.
• 10+ years in software quality assurance within regulated environments.
• Experience with IDE, PMA, or similar regulatory pathways.
• Strong understanding of SDLC and design controls (traceability).
• Hands-on software verification and validation using risk-based approaches.
• Familiarity with FDA regulations (21 CFR 820/812/814).

Responsibilities

• Serve as Senior Design Quality Engineer on product teams, ensuring design controls across lifecycle.
• Establish and maintain DHF, DMR, and DHR with traceability from needs to verification/validation.
• Lead risk management activities and integrate risk controls into design/validation.
• Provide quality oversight of software SDLC activities per standards (IEC 62304).
• Review and approve design, software, and validation deliverables for audit readiness.
• Support verification, validation, and design transfer activities aligning design outputs to production.

Skills

Quality assurance

Risk management

SDLC knowledge

Regulatory compliance

Stakeholder communication

Analytical skills

Software verification

Audit readiness

Education

Bachelor's degree in engineering

Business or CS background

Tools

SOPs improvement

Test management

Defect tracking

Quality documentation tools

Job description

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 mostinnovative companies unleash their potential. From autonomous cars to life‑saving robots, our digital and software technology experts think outside the box as theyprovide 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 arethe same.

Location

Hybrid (minimum 3 days onsite) – Andover, MA OR Remote

About The Job You’re Considering

Capgemini Engineering is seeking a Senior Design Quality Engineer- Medical Devices. 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.

Your role

• 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)

Your Skills And Experience

• 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)
• Should have embedded development/ Digital Platform background Or exposure to embedded development / Digital Platform within Medical Devices domain (preference class II OR III)
• 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

The base compensation range for this role in the posted location is: 68,911 - 150,350

Capgemini provides compensation range information in accordance with applicable national, state, provincial, and local pay transparency laws. The base compensation range listed for this position reflects the minimum and maximum target compensation Capgemini, in good faith, believes it may pay for the role at the time of this posting. This range may be subject to change as permitted by law.

The actual compensation offered to any candidate may fall outside of the posted range and will be determined based on multiple factors legally permitted in the applicable jurisdiction.

These may include, but are not limited to: Geographic location, Education and qualifications, Certifications and licenses, Relevant experience and skills, Seniority and performance, Market and business consideration, Internal pay equity.

It is not typical for candidates to be hired at or near the top of the posted compensation range.

In addition to base salary, this role may be eligible for additional compensation such as variable incentives, bonuses, or commissions, depending on the position and applicable laws.

Benefits

Capgemini offers a comprehensive, non‑negotiable benefits package to all regular, full‑time employees.

In the U.S. and Canada, available benefits are determined by local policy and eligibility and may include:

• 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
• Other benefits as provided by local policy and eligibility

Important Notice:

Compensation (including bonuses, commissions, or other forms of incentive pay) is not considered earned, vested, or payable until it becomes due under the terms of applicable plans or agreements and is subject to Capgemini’s discretion, consistent with applicable laws. The Company reserves the right to amend or withdraw compensation programs at any time, within the limits of applicable legislation.

Disclaimers

Capgemini is an Equal Opportunity Employer encouraging inclusion in the workplace. Capgemini also participates in the Partnership Accreditation in Indigenous Relations (PAIR) program which supports meaningful engagement with Indigenous communities across Canada by promoting fairness, accessibility, inclusion and respect. We value the rich cultural heritage and contributions of Indigenous Peoples and actively work to create a welcoming and respectful environment. All qualified applicants will receive consideration for employment without regard to race, national origin, gender identity/expression, age, religion, disability, sexual orientation, genetics, veteran status, marital status or any other characteristic protected by law.

This is a general description of the Duties, Responsibilities and Qualifications required for this position. Physical, mental, sensory or environmental demands may be referenced in an attempt to communicate the manner in which this position traditionally is performed. Whenever necessary to provide individuals with disabilities an equal employment opportunity, Capgemini will consider reasonable accommodations that might involve varying job requirements and/or changing the way this job is performed, provided that such accommodation does not pose an undue hardship. Capgemini is committed to providing reasonable accommodation during our recruitment process. If you need assistance or accommodation, please reach out to your recruiting contact.

Please be aware that Capgemini may capture your image (video or screenshot) during the interview process and that image may be used for verification, including during the hiring and onboarding process.

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.