Senior System Engineer - Medical Device
Capgemini Engineering Sverige AB / Sjukhusteknikerjobb / Stockholm
2025-06-17
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hela Sverige 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.
Your role
As a consultant in our life science team, your role will be a System engineer and work for medical devices clients, helping them with new product design and development. You will be creating product documentation right from the conceptual design to the product validation and all the way to product sustaining and handling of design changes.
As a System Engineer you will:
• Incorporate essential operating mechanisms of systems engineering of medical device design and adhere to medical device regulations.
• Participate in identifying and planning tasks, activities, and resource needs related to systems engineering.
• Leverages knowledge of technology, process, and/or therapy domains to drive solutions and product design realization from a systems perspective.
• Defines system requirements, architecture, and interfaces to meet product requirements, risk analysis and industry standards.
• Creates design concepts and research methodologies that best meet current and future customer & business needs for a product or process domain area.
• Conducts system design analysis to select key components and defines control methods; and coordinates build and design integration.
• Understands clinical and user needs and can apply to product realization.
• Works together to support product verification and validation planning, resolution of technical integration issues, and coordinate system testing.
• Demonstrates understanding of and adherence to FDA, ISO and IEC design control procedures, regulations, and standards.
• Drives Change Control Management records as Change owner and ensure timely closure.
• Creates and maintains Design History File elements.
• Conducts design reviews as part of the product development process to ensure customer requirements are met and the designs are manufacture-able, serviceable, and reliable.
• Successfully influences stakeholders and cross-functional team members within the project.
Your profile
• A degree in Electrical/Mechanical/Biomedical Engineering (or) related engineering discipline with 6 plus of experience.
• Deep knowledge of systems engineering disciplines and related areas for medical devices (such as Electro-mechanical systems, embedded hardware and software).
• Knowledge of and/or experience of working accordance with regulations, guidelines, and standards such as: EU MDR, US FDA, IEC 60601, ISO 13485, ISO 14971 etc.
• The ability to communicate fluently in spoken and written English.
• A valid work permit for Sweden.
You as a person are:
• Curious and motivated by exciting challenges,
• A person who takes initiatives, is flexible and thrives in a dynamic environment,
• A person who finds it easy to cooperate and communicate with different groups of people,
• Genuinely interested in technology and problem solving, and
• Driven by challenges and personal development.
What we believe you will enjoy about working here
• We recognize the significance of flexible work arrangements to provide support. Be it remote work, or flexible work hours, you will get an environment to maintain healthy work life balance.
• At the heart of our mission is your career growth. Our array of career growth programs and diverse professions are crafted to support you in exploring a world of opportunities.
• We support your personal development and offer an education library with more than 250 000 (!) courses and educations and certifications.
About Capgemini
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. The Group reported 2024 global revenues of EUR22.1 billion. Get The Future You Want |
www.capgemini.com Så ansöker du Sista dag att ansöka är 2025-11-28
Klicka på denna länk för att göra din ansökan Omfattning Detta är ett heltidsjobb.
Arbetsgivare Capgemini Engineering Sverige AB (org.nr 556542-2531)
Fleminggatan 18 (
visa karta)
112 26 STOCKHOLM
Arbetsplats Capgemini engineering Stockholm
Jobbnummer 9391784