Requirements Engineer for Medical Devices
Are you able to write, maintain and control requirement documentation for medical devices? Do you have experience of participating in product development projects and creating and maintaining system documentation? And, do you want to join a successful company in rapid growth? Then your next career move may be with Ambu.
We want to continue being the global leader developing and manufacturing single-use endoscopes. In this newly established and challenging position, you will work in the very heart of our global innovation, and you will be an active contributor to Ambu’s success developing single-use endoscopes.
You will be part of a dynamic innovation culture characterised by a strong team spirit. Our Global Innovation team consists of 120 people located at our headquarters in Ballerup. You will join a team of highly skilled and international professionals.
Requirements and systems engineering for our endoscopes
Working in and across multi-disciplined teams, you will be responsible for:
- Managing requirements across the whole lifecycle, however with a strong focus on the early stages of product development. This will include capturing and analysing all stakeholder requirements – internal as well as external -, maintaining full traceability at all levels, and documenting the results of verification activities to demonstrate compliance.
- Act as project resource to create and maintain system documentation including but not limited to: Design Input, Risk management and planning in cooperation with test team.
- Identifying user needs through participating in projects.
Your contact base will be broad, and you will interface with Ambu’s global organisation and external partners and subcontractors and with consultants and suppliers.
You should have a proven ability to deliver to agreed cost, schedule, and quality performance targets. Your role will require you to develop excellent working relationships with all areas of the organisation and therefore an element of travel is to be anticipated.
Experience form the medical device industry working with product development, risk management and Usability/HFE.
An experienced medical device requirements/system engineer
You most likely have an engineering degree or related scientific discipline within Mechanics or Systems. You must have about 10 years of experience in developing medical devices and have a thorough knowledge of Design Control, ISO13485 and related regulatory requirements. Specific experience required within:
- Capturing, analysing, reviewing and specifying requirements.
- Management of all levels of requirements to enable design and development decisions
- Managing test and requirements traceability to achieve certification and delivery
- Working with and influencing key project stakeholders
- Preferably experience working with and managing requirements databases
- Actively support knowledge sharing and exploitation of best practice
As a person, you work independently, and you take responsibility for your tasks. You are self-motivated, committed, detail-oriented and structured. Additionally, you have sense of occasion, great interpersonal skills and you thrive in global teams.
Since we are a global company, you will be involved in cross-cultural collaboration and you will join an international team. Consequently, you must be fluent in English and be able to communicate efficiently. Lastly, you thrive in a position that gives you the opportunity to travel approximately 20 days a year when this is possible again.
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 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.
How 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 30th November 2020 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 Niels Bjerrum Thomsen at +45 7225 2587 Ring op: +45 7225 2587
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 4,200 people in Europe, North America and the Asia Pacific. For more information, please visit www.ambu.com
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