Project Manager for Medical Device and SaMD Development

Job Description

Do you want to be part of our young and fast growing Engineering team in DK, helping to shape and set the pace for our future?

At Capgemini Engineering, you are part of something bigger. Our close cooperation with other entities within the Capgemini Group will give you the opportunity to explore endless possibilities. We have offices all over the world, and the Capgemini family consists of more than 340 000 colleagues globally.

We all need to adapt to the new normal and be aware that the world is constantly changing. We offer a flexible work policy, where you can work a large part of your time from home or wherever it suits you best. The arrangement is put in dialogue with the immediate manager and adapted to needs, assignments and the customer’s wishes.

We support your personal development and offer an education library with more than 250 000 (!) courses and educations and certifications. We encourage internal promotions and your continuous growth within our company.

In Denmark we are a smaller but fast-growing engineering part of the overall Capgemini organization. You’ll therefore have a unique opportunity to help us shape our future with regards to direction, setup, and ways of working.

For our clients within the Medical Device an SaMD space, we are looking for an experienced Project Manager, to help us succeed on our larger project engagements.

We are this year focusing on our engagement in Life Science, but will gradually move into other areas e.g. Manufacturing and Industry 4.0 helping the automation, efficiency and sustainability agendas.

You’ll be working in a very international setup, with engagements based on our Rightshore® model, where we’ll have a local presence at the client, but will use our colleagues Nearshore and Offshore in our setup.

Your role

• Plan and execute projects for our clients, either on site in their organization or as projects done entirely by Capgemini Engineering for the client

• Ensure we meet our commitments and targets

• Define and manage risks

• Be the center point for securing the compliance to regulatory standards like MDR EU 2017/745, ISO 13485, FDA 21 CFR 820, and SaMD

• Working closely together with our team across all competences, sites and countries

• Facilitate workshops on best ways to work together with the client to be most successful together

• Being a sparring partner to younger team colleagues both at the office and in the engagement with clients

• Proactively drive process work together with the client to gain efficiency, and to ensure quality

• Establish and maintain project documentation according to the QMS system used

• Help establish, maintain, and control requirements on client projects

• Help interpreting and incorporating relevant regulatory requirements and product standards (e.g. FDA and MDR) into the product requirements

• Help or facilitate the change management process and documentation

• Be part of pre-sales activities to define and describe solutions to prospect clients

Qualifications

• University degree or equivalent within engineering

• At least a few years of experience and a proven track-record of Project Management for Medical Device or SaMD projects

• Minimum 5 years of experience with end-to-end product development

• Agile development experience

• Fluent in Danish spoken and written language (as this is required by some of our clients) and English

Application and contact

If you have any questions regarding the job opening or your application, please contact Talent Acquisition Team lead, Anette Nilsen, at + 46 730250517 or Director of Delivery Capgemini Engineering Denmark, Mads Madsen at +45 52 18 90 03