Standard Specialist, Global Innovation

-for a fast growing and innovative medical device company

Do you have experience with standards for medical devices? Do you want to be a part of product development and maintenance? Are you motivated by making a difference for your customers by making sure our products always set and meet the highest level of performance, from a user perspective? Do you want to focus on setting the bar for how to develop sustainable medical devices? Then your next career move may be with Ambu as Standard Specialist in our team, Innovation Processes, Global Innovation.

In this newly established and challenging position, you will be an active contributor in the innovation team taking a role as a Standard Specialist. You will be charged with keeping an overview of applied standards across Ambu’s product portfolios, and being Ambu’s representative in European ISO standard committees, helping to shape the future of medical device development. You will take part in development projects, and make sure Ambu is prepared for the future trends in regulations, and that regulations are formed based on patient safety and user needs.

You will be part of an effective innovation culture with a tradition for fast completion of projects, which means that there will be a visible link between your results and Ambu’s growth. You will be a member of the Innovation Process team that currently focuses on supporting and guiding our Global Innovation organization on our business processes, Design Control processes and much more. Your focus will be on the full Ambu portfolio, covering both our Anesthesia, Patient Monitoring & Diagnostics and Visualization products. Our Global Innovation team consists of 120 people and is located at our headquarters in Ballerup. We focus on developing new products and improving and maintaining our current products, combining technologies in new and innovative ways. This puts high demands on your skills and requires broad experience.

Active involvement
As Standard Specialist, you will be a vital player in both product development projects and product maintenance, and you will be involved in all aspects of the innovation process – from the conceptual design to the product validation.

User driven innovation is in Ambu’s DNA, and we believe ISO standards should be based on user needs, which means that you will participate in the interaction with doctors, customers and users of the products as a natural part of the standard work.

Your main responsibilities will be:

• To maintain an overview of applied standards across all Ambu products.
• To provide product innovation projects with inputs regarding what ISO standards should be considered for the project.
• To review standard updates and clarify the technical implications for Ambu products.
• To be an active participant in standard committees, both in Dansk Standard but also in an European setting.
• To keep the users, key opinion leaders, doctors and other experts worldwide, in mind in order to make sure that the standards across Europe and the world in general, are tailored to ensure that medical devices fulfill the user needs.
• Stakeholder management and coordination across various in-house functions including, but not limited to Project Management, Marketing, RA, QA, Clinical, Production, and Procurement.

Your contact base will be broad, and you will collaborate with Ambu’s global organisation, all departments involved in product development projects and externally with users, knowledge centers and committees.

Experienced medical device engineer
Ideally, you hold an educational background within engineering or similar.

You have at least 5 years within medical devices, or another heavily regulated area, working with ISO standards. Most likely, you are employed in a similar job within the medical device industry or in a consultancy that deals with the medical device field.

As a person you are self-motivated, committed and have a strong sense of responsibility towards your work. You are thorough and detail-oriented but at the same time you have great interpersonal skills and have a sense of the situation, which makes you thrive in global teams. You are a “do’er” and prefer to act on rather than theorize about problems. You have a flair for the written word, political clout, solid technical insight and a passion for shaping the guidelines and standards for the medical device industry of the future.

Since we are a global company, you will be involved in cross-cultural collaboration. Consequently, it is a requirement that you are fluent in English and that you are able to communicate efficiently. Lastly, you thrive in a position that gives you the opportunity to travel approximately 20-30 days a year.

Ambu – an ambitious and professional workplace
Ambu is a company with ambitious growth objectives and we are very focused on developing and putting innovative products to market. We reach our objectives through an interdisciplinary collaboration between motivated and competent colleagues in an informal work environment. Our rapid development means that there is a natural focus on the ongoing development of your professional and personal skills that will help to ensure Ambu's continued success.

We offer a wide range of professional, social and economic benefits, in addition to the exciting challenges of the job.

When to apply
If you are ready to apply for the position, please apply as soon as possible. Note that we will invite candidates for interviews on a continuous basis so no need to hesitate. This job ad might be online until 31 July 2020, due to the summer holiday but once we have found the right candidate, the ad will no longer be online.

Your application will of course be treated confidentially.

You can get additional information about the job and about Ambu by contacting Jakob Bønnelykke Kristensen, Senior Director, Anesthesia & Patient Monitoring, Global Innovation before week 29 / after week 31 on +45 7225 2000

About Ambu
Since 1937, breakthrough ideas have fuelled our work on bringing efficient healthcare solutions to life. This is what we create within our fields of excellence – Anaesthesia, Patient Monitoring & Diagnostics, and Emergency Care. Millions of patients and healthcare professionals worldwide depend on the functionality and performance of our products. We are dedicated to improve patient safety and determined to advance single-use devices. The manifestations of our efforts range from early inventions like the Ambu Bag™ resuscitator and the legendary BlueSensor™ electrodes to our newest landmark solutions like the Ambu aScope™ – the world’s first single-use flexible endoscope. Our commitment to bringing new ideas and superior service to our customers has made Ambu one of the most recognized medical companies in the world. Headquartered near Copenhagen in Denmark, Ambu employs approximately 3,500 people in Europe, North America and the Asia Pacific. For more information, please visit www.Ambu.com