Senior System Engineer - Medical Device

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.

• 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.

• 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

The Group reported 2024 global revenues of €22.1 billion. Get The Future You Want | www.capgemini.com