Non Product Validation Engineer
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.
About the role you're considering
We are seeking a detail-oriented Non-Product Software (NPS) Validation Engineer to join our medical technology team. This role is responsible for ensuring that all non-product software systems used in our quality management system processes comply with ISO 13485 standards and applicable regulatory requirements. The ideal candidate will have strong technical skills combined with a thorough understanding of medical device quality systems, validation methodologies, and embedded systems experience.
Location
This role will be on-site in Dallas, TX
Your role
- Plan, execute, and document validation activities for non-product software systems in accordance with ISO 13485 requirements
- Develop validation protocols including requirements specifications, risk assessments, test plans, and validation reports
- Conduct gap analyses of existing systems against regulatory requirements
- Create and maintain validation documentation including traceability matrices
- Collaborate with IT, Quality, and other cross-functional teams to ensure software systems meet business needs while maintaining compliance
- Participate in internal and external audits related to software validation
- Support change control processes for validated systems
- Develop and implement validation strategies for new software implementations
- Monitor and evaluate system performance to ensure continued validated state
Your skills and experience
- Bachelor's degree in Engineering, Computer Science, or related technical field
- 1-3 years of experience in software validation within a regulated medical device environment
- Demonstrated knowledge of ISO 13485 requirements for non-product software validation
- Proficiency in risk management techniques (FMEA, FTA) as applied to software systems
- Strong understanding of 21 CFR Part 11 compliance for electronic records/signatures
- Excellent documentation and technical writing skills
- Strong analytical and problem-solving abilities
- Effective communication skills with the ability to explain technical concepts to non-technical stakeholders
Preferred Qualifications
- Master's degree in related field
- Knowledge of additional regulatory frameworks (FDA QSR, EU MDR, MDSAP)
- Background in computer system validation methodologies
- Experience with validation of computerized systems in medical device environments
- Familiarity with embedded software development lifecycles
The base compensation range for this role in the posted location is: $46,400 - $111,090
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 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.
Click the following link for more information on your rights as an Applicant in the United States. http://www.capgemini.com/resources/equal-employment-opportunity-is-the-law
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.
Dallas, TX, US
Nearest Major Market: Dallas
Nearest Secondary Market: Fort Worth