Senior Design Control Specialist
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Ballerup
The GN Group is a global leader in intelligent audio solutions that let you hear more, do more and be more than you ever thought possible. Their ambitious 150-year journey has taken them from telegraph cables to radio waves and intelligent audio engineering. To celebrate this anniversary, GN looks to their unique competences within medical, professional and consumer audio solutions to help them continue to transform lives through the power of sound.
GN was founded with a truly innovative and global mindset. Today, they honor that legacy with world-leading expertise in the human ear, sound, wireless technology, miniaturization and collaborations with leading technology partners.
At GN’s headquarters in Ballerup, you will join 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, the departments combine forces to make sure that new and existing products gain market access across all markets.
Combining forces through strong teamwork is vital in order to make sure that new and exciting products gain market access.
The team is highly experienced within design control knowledge, software, risk, usability and provides support within these areas to the organization.
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:
Preferably you hold a master’s degree, e.g. in mechanical engineering, chemistry, software or similar
GN was founded with a truly innovative and global mindset. Today, they honor that legacy with world-leading expertise in the human ear, sound, wireless technology, miniaturization and collaborations with leading technology partners.
At GN’s headquarters in Ballerup, you will join 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, the departments combine forces to make sure that new and existing products gain market access across all markets.
Combining forces through strong teamwork is vital in order to make sure that new and exciting products gain market access.
The team is highly experienced within design control knowledge, software, risk, usability and provides support within these areas to the organization.
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
Preferably you hold a master’s degree, e.g. in mechanical engineering, chemistry, software or similar
- A minimum of 5 years experience with risk management, usability and software from the medical device industry.
- General design control knowledge and some regulatory experience
- 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
- Communicate effortlessly in spoken and written English
Information og data
Denne ledige stilling har jobtypen "Afdelingsleder", og befinder sig i kategorien "Ledelse og personale".
Arbejdsstedet er beliggende i Ballerup.
Jobbet er oprettet på vores service den 29.1.2021, men kan have været deaktiveret og genaktiveret igen.
- Afdelingsleder
- Ballerup
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Statistik over udbudte afdelingsleder i Ballerup over tid
| Dato | Alle jobs som afdelingsleder |
|---|---|
| 7. oktober 2024 | 9 |
| 6. oktober 2024 | 8 |
| 5. oktober 2024 | 8 |
| 4. oktober 2024 | 9 |
| 3. oktober 2024 | 11 |
| 2. oktober 2024 | 11 |
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| 29. september 2024 | 11 |
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| 27. september 2024 | 12 |
| 26. september 2024 | 12 |
| 25. september 2024 | 13 |
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| 7. september 2024 | 10 |