System Engineer For Medical Devices

World leader in engineering and R&
D services, Capgemini Engineering combines its broad industry knowledge and cutting-edge technologies in digital and software to support the convergence of the physical and digital worlds. Coupled with the capabilities of the rest of the Group, it helps clients to accelerate their journey towards Intelligent Industry. Capgemini Engineering has more than 55,000 engineer and scientist team members in over 30 countries across sectors including Aeronautics, Space, Defense, Naval, Automotive, Rail, Infrastructure &
Transportation, Energy,Utilities &
Chemicals, Life Sciences, Communications, Semiconductor &
Electronics, Industrial&
Consumer, Software &
Internet.

Capgemini Engineering is an integral part of Capgemini, a global leader in partnering with companies to transform and manage their business by harnessing the power of technology. The Group is guided everyday by its purpose of unleashing human energy through technology for an inclusive and sustainable future. It is a responsible and diverse organization of over 360,000 team members in more than 50 countries. With its strong 55-year heritage and deep industry expertise, Capgemini is trusted by its clients to address the entire breadth of their business needs, from strategy and design to operations, fueled by the fast evolving and innovative world of cloud, data AI, connectivity, software, digital engineering and platforms. The Group reported in 2022 global revenues of €22 billion.

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.

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.

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.

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.

At Capgemini Engineering we value excellence, care, responsibility, dynamism and innovation. We offer a job with variation that leaves plenty of room for initiative and development. In fact, we are not just offering you a job, we’re inviting you to be part of our community where we will provide you trainings, tools &
grounds for professional and personal growth. Each career experience is assorted by an attractive salary package.

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