Are you able to write, maintain and control requirements 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 in the development and manufacturing of 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 in 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 70 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 analyzing all stakeholder requirements - internal as well as external - maintaining full traceability at all levels, and documenting the results of verification activities to demonstrate compliance.
- Establishing a process and best practice for creating, maintaining and controlling requirements (incl. related documents and SOPs for documentation) for single-use endoscopes and related accessories.
- Acting 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
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.
An experienced medical device requirements/systems engineer
You most likely hold a degree in engineering 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, risk management, usability/HFE and related regulatory requirements.
It is important that you are able to capture, analyze, review and specify requirements and that you have managed all levels of requirements to enable design and development decisions. Preferably, you also have experience working with requirements databases.
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, thrive in global teams and you actively support knowledge sharing.
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 that you are able to influence key project stakeholders.
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 20-30 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 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 7 August 2019, 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 Director, Mechanical Engineering Niels Bjerrum Thomsen +45 7225 2000.
Please write in your application that you've seen the job at Jobfinder.