Sr. Software Developer Quality Engineer- Medical Devices
Job Location:
Burlington - Canada
Monthly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
At Capgemini Engineering the world leader in engineering services we bring together a global team of engineers scientists and architects to help the worlds 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 youre considering
Capgemini Engineering is seeking a Senior Design Quality Engineer- Medical Devices. You will be responsible for ensuring endtoend 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 postmarket 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
- Bachelors 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).
- 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: 68911 - 150350
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.
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 Capgeminis 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.
Click the following link for more information on your rights as an Applicant in the United States. 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 340000 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.
Required Experience:
Senior IC
About Company
A global leader in consulting, technology services and digital transformation, we offer an array of integrated services combining technology with deep sector expertise.
