Life Science Consultants Digital Health

Job Description

Are you passionate about quality management and regulatory affairs related to development of Software as Medical Device (SaMD) or Digital Therapeutics?

Join us and get the future you want!

Capgemini Engineering are in a global leading position within innovation, development and engineering. Together with our partners we are facing exciting challenges whilst building the future. Our team is taking their efficiency, quality and compliance to the next level in order to develop smarter products and become an even stronger player within the life science sector.

Our offer
By offering exciting opportunities of career development you can get the future you want.

Capgemini Engineering offers you a work environment that is characterized by innovation. As a consultant at Capgemini Engineering, you are part of something bigger. We deliver, together with our global centers of expertise, solutions for both large global customers and smaller local start-ups. We are driven by meeting the customer's needs and generating added value. In the Life Science Team in Malmö, we work mainly with medical devices, as Capgemini Engineering Sweden is certified under ISO 13485.

Your Role
As a consultant in our life science team, you will be working with quality management in development projects related to SaMD and/or digital therapeutics. In many of our client assignments, our consultants work in teams provided to the client by Capgemini Engineering – but in close collaboration with employees of the client. You will be working in accordance with Capgemini Engineering’s processes for design control and project management as well as with applicable standards, legislations and client-specific processes in order to ensure quality assured activities and documentation during the design and development.

You as an individual are self-driven, not driven by prestige and a team-player. You are comfortable with leading others and interested in taking the driver’s seat with regards to your own development. You find the consultant role interesting and thrive in a varied environment where changes sometimes take place with abrupt changes.Your Profile

• A degree in engineering /Master of Science/ pharmacy degree or similar.
• Experience within development (design control) and regulatory submission of medical devices (preferably SaMD).
• Knowledge of and/or experience of working accordance with: ISO 13485, ISO 14971, IEC 62366 and/or IEC 62304.
• The ability to communicate fluently in spoken and written English and Swedish.
• Curious and motivated by exciting challenges.

We are looking for a person who take initiatives, are flexible and thrive in a dynamic environment. A person who finds it easy to cooperate and communicate with different groups pf people. Genuinely interested in technology and problem solving, and driven by challenges and personal development.

About Us
Capgemini Engineering (formerly Altran) is one of the world’s leading consultant companies within R&D. We are part of Capgemini Group with around 270 000 employees globally. In Scandinavia, our main areas of business are Industry, Automotive, Life Science and the Public Sector. Together with our global centers of expertise, we deliver solutions to both global clients and local start-up companies.

Based on the need of the client, we provide competence, complete project teams and services. We always adapt our solutions and services to the client’s organization and challenges.

Our organization is characterized by a team spirit atmosphere and leaders who’s main focus is to support the consultants in their projects – all in line with our core values Ambition & Care. We actively work to promote participation by regularly organize team breakfasts and lunches, after works, sport events and other fun activities!

We care about our employees, and to us it is important that all our employees have a close connection to their teams as well as team managers.