Are you prepared to be the expertise lead, utilising your extensive knowledge within device development in an exciting role?

As Senior Risk Manager at Technolution, you will be the leading expert and actively participate in client projects and assist in identifying, assessing, and managing risks associated with the development of medical devices, especially combination products.

You will be part of a team of 10 nice and nerdy colleagues in the Design Control Team, and you will collaborate across projects with colleagues from User Experience & Design, Usability Engineering, QA, Labeling, and Mechanical Engineering on the various assignments.

You will play a vital role

Besides being our technical expert within Risk Management, you should also be excited to take on tasks in related areas such as Design Control and Quality Management. It is expected that you thrive as a mentor for colleagues and that you enjoy sharing your knowledge and expertise and help other people grow.

Your qualifications

In this role, it is believed that you have been engaged in several medical device development projects. You have experience with medical devices, particularly combination products, and the ability to identify and assess potential risks. In addition, familiarity with regulatory requirements and working collaboratively with various stakeholders is vital to ensuring patient safety and product quality. You have extensive hands-on experience with the ISO 14971 standard, ISO 13485, 21 CFR Part 820, and contributing with input to submissions for CE marking, and FDA 510(k).

You have a master’s degree in Engineering, Pharmacology, Molecular Biology, or similar.

You are a person who takes a holistic view of the development process, and you thrive on working with highly qualified teams on diverse projects with clients ranging from start-ups to industry leaders. You find it natural to build good relations with clients and colleagues.

Technolution is based in Hørsholm, North of Copenhagen, Denmark. The company, a market leader in its field, currently employs 77 people across multiple disciplines and has to date handled 240+ projects over the past twenty years. During that time, Technolution has gained a reputation as an expert in transforming ideas into innovative healthcare solutions. You will be offered a unique opportunity to flourish and enhance your skill set within an collaborative atmosphere. Today, Technolution is part of the US-based MGS group, which, besides Denmark, has locations in the US, Germany, Ireland, Sweden, and Mexico. Read more about it at Technolution joins forces with MGS – Technolution (technolution-tn.com).

Place of work: Mainly at the client’s site and each Friday at the office.

For more details about the job or the company, please contact Account Director Belinda Bramsnæs, Unique Human Capital, on M: +45 28 44 28 44 or E-mail beb@uhc.dk or Senior Research Consultant Anne Thomsen, Unique Human Capital on M: +45 31 40 01 11 or E-mail ant@uhc.dk. All applications must be in English and are treated confidentially.