Senior Design Control Specialist
Would you like to collaborate with colleagues and external stakeholders from across the world to ensure smooth and efficient market access?
Making life sound better around the globe
As part of a global leader in intelligent audio solutions, GN Hearing provides people across the world with advanced hearing aids that let them hear more, do more and be more than they ever thought possible.
At our HQ in Ballerup, you will become part of the Design Control team in Corporate Quality where you will meet 3 colleagues, all specialized within their own area of expertise. As part of Global R&D, we combine forces to make sure that new and existing products gain market access across all markets.
Drive and teach efficient design control compliance
You will be supporting the projects in the R&D organization on everything regarding design control. This entails contributing to the progress of product development projects and ensuring that we share our knowledge within the teams. It also includes planning, reporting and documenting the work in close cooperation with a variety of stakeholders.
A significant part of your role will also be to plan and implement the design control documentation, including usability engineering and risk management, in compliance with current regulatory standards for medical device development.
More specifically, you will:
- Participate in integrating risk management and usability engineering activities
- Identify and analyze risks and define mitigations in collaboration with development teams
- Ensure continuous improvement and optimization of GN Hearing Design Control procedures and templates in collaboration with the other departments
- Participate in design and technical file reviews
- Carry out in-house training of the organization in design control processes
“Our aim is always to have great collaboration with R&D. Design control should never be policing, rather it’s about teamwork. That is our ultimate goal,” explains Design Control Compliance Manager Anita Fjaestad.
Design control specialist within medical devices
As a person, you spot the great opportunities and have a structured approach to your work. You are able to listen to understand where your colleagues are coming from – and you communicate your thoughts on guidelines/recommendations to colleagues, focusing on close collaboration. It is all about creating that common ground for R&D and your team. Moreover, we imagine that you:
- Preferably hold a master’s degree, e.g. in mechanical engineering, chemistry, software or similar, but most importantly, you have some years of experience with the development of medical devices and design control
- Have a good understanding of and experience with ISO 13485, ISO 14971, MDR, IEC 62366-1 and possibly with FDA requirements for the development of medical devices
- Have experience with creating requirements, test plans, test protocols and test reports
- Have experience with usability and risk management
- Communicate effortlessly in spoken and written English
Would you like to know more?
To apply, use the ‘APPLY’ link no later than 27 October, 2020. Applications are assessed on a continuous basis, which is why we encourage you to send your application as soon as possible.
If you want to know more about the position, you are welcome to contact Design Control Compliance Manager, Anita Fjaestad on +45 27 88 96 49.
Please write in your application that you've seen the job at Jobfinder.