R&d Medical Device Project Manager

vor 1 Tag

Lausanne, Schweiz Capgemini Engineering Vollzeit

Capgemini Engineering combines, under one brand, a unique set of strengths from across the Capgemini Group: the world leading engineering and R&D services of Altran - acquired by Capgemini in 2020 - and Capgemini's digital manufacturing expertise. With broad industry knowledge and cutting-edge technologies in digital and software, Capgemini Engineering supports the convergence of the physical and digital worlds. Combined with the capabilities of the rest of the Group, it helps clients to accelerate their journey towards Intelligent Industry. Capgemini Engineering has more than 52,000 engineer and scientist team members in over 30 countries across sectors including aeronautics, automotive, railways, communications, energy, life sciences, semiconductors, software & internet, space & defence, and consumer products.
Capgemini Engineering is an integral part of the Capgemini Group, a global leader in partnering with companies to transform and manage their business by harnessing the power of technology. The Group is guided every day by its purpose of unleashing human energy through technology for an inclusive and sustainable future. It is a responsible and diverse organization of 270,000 team members in nearly 50 countries. With its strong 50-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 2020 global revenues of €16 billion.

**Nuestra oferta**:
To strengthen our team in Switzerland we are looking for a Medical Device Project Manager. As a Capgemini Engineering Consultant you play a key role in the research and the development of new class I II or III medical devices (instrument, apparatus, implant, in vitro reagent).

**Descripcion General**:

- You will:

- Coordinate and Manage R&D activities.- Design and develop Medical Devices.
- Be responsible for Product Safety.- Specify and perform acceptance tests (performance, statistical quality, verification, validation) in collaboration with internal laboratories (design verification, design control).
- Communicate with and manage suppliers.
- Ensure compliance to quality standards and regulatory requirements (FDA, CE Marking, ISO 13485).
- Provide Technical Documentation and build up Design History File of the products.

**Perfil**:
Your Profile:
Education level:
Master or Engineering Degree in Mechanical / Bio-Medical / Embedded System Engineering (EPFL, ETH, HES or equivalent) with emphasis on Medical Device development.
- Requirements:
- Minimum 5 to 7 years of program/project management with close customer or partner relationship in the medical device industry.
- Proven experience in leading project development phase until the market launch of a medical device at high volume.
- Proven experience in leading feasibility stage of a complex medical device.
- Relevant related technical experience or background in the medical devices regulated industry (e.g. ISO13’485; CFR21 part 11, IEC62304, others).
- Ability to manage financial aspects of a project or program.
- Capacity to follow V&V cycle product development.

Languages: French as well as English.
- Ready to join?Capgemini Engineering will be on the forefront in creating an optimal work-life balance, more autonomy in where and how our people work and to embrace the learnings we have experienced from wider-scale remote working. For you, this may mean less time in the office than usual with some time working from home, whereas other roles and engagements will continue to be more location-dependent or office-based. Together with your manager, you will agree an approach which works for you, your team and our business.

In order to deploy this novel way of working, we have introduced our **New Normal** policy which includes:

- 30% to 70% remote work in agreement with your line manager and client needs
- Trust-based managerial culture
- Team rituals and get togethers
- Options to order ergonomically proven Equipment (monitor & chair) for your home office premises.

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