Design Control Specialist / System Engineer
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Kongens Lyngby
PharmaRelations is the Nordic market leader within talent services for the life science industry. We specialise in partnering with some of the top and most innovative organisations exclusively in the Life Science sector across our region. We add value to our clients and candidates with our consultancy services, outsourcing solutions and recruitment of specialists and leaders.
We are currently partnering with CathVision, a maturing start-up company whose mission is tocure cardiac arrhythmia by empowering healthcare professionals with cutting-edge technology by using recording and AI algotims.CathVision are maturing quickly and has reached a point where they need to strengthen their R&D team with a dedicated Design Control Specialist with an in dept technical under-standing or a System Engineer, in Copenhagen, Denmark.
In this job, you will be the bridge between the Software Developers and the Regulatory world, by ensuring the software description is understandable in the Regulatory context.
On a daily basis you will work closely with CathVision’s Regulatory team, the 4 other members of the System Engineering team, our software team and the R&D teams as well as QA/RA.
You will be part of projects with up to 20 participants, including suppliers in the US and Canada. Projects will mainly focus on updates of software, design, documentations.
In this role we are looking to welcome a team member that is self-motivated and can structure and manage own tasks. You possess good communication and interpersonal skills, while - at the same time - has a structured working method, eye for details and a pragmatic openminded approach.
Furthermore, you have an in depth understanding of the software solution. You are familiar with the regulatory requirements and possess a professional experience in development and realization of new products in an R&D environment.
Maybe you have a background in medical device development and a solid experience from working with the associated documentation in the technical file as well as knowledge and experience with product development in accordance with ISO 13485, ISO 14971, QSR, and MDR.
You:
Our offer:
We offer flexible hours, and a lot of freedom. We organise social events during the year that ensure you get to know your colleagues and help make CathVision a nice place to work.
Who are we?
CathVision currently have approximately 26 employees, of which most are working with product development. The organization will be expanded further in 2022. We work in an informal environment and value teamwork, self-management, and continuous learning.
Cath Vision expect to get FDA clearance for the first product, the ECGenius System, in 2022.
How?
For further information do reach out to Recruitment Manager, Lise Sønnersgaard, on telephone no. 60 98 13 03 or [email protected] or apply directly here. Due to GDPR, we cannot receive any CVs via e-mail. Interviews are already taking place, so please get in touch or apply at your earliest convenience.
At PharmaRelations we are committed to being an employer of equal opportunities for all and recruitment practices shall be free from discrimination based on race, color, ancestry, national origin, ethnic group identification, age. Religion, material or parental status, physical or mental disability, sex, sexual orientation, gender, gender identification or expression, or genetic information; the perception of one or more of such characteristics; or associated with a person or group with one or more of these actual or perceived characteristics.
We are currently partnering with CathVision, a maturing start-up company whose mission is tocure cardiac arrhythmia by empowering healthcare professionals with cutting-edge technology by using recording and AI algotims.CathVision are maturing quickly and has reached a point where they need to strengthen their R&D team with a dedicated Design Control Specialist with an in dept technical under-standing or a System Engineer, in Copenhagen, Denmark.
In this job, you will be the bridge between the Software Developers and the Regulatory world, by ensuring the software description is understandable in the Regulatory context.
On a daily basis you will work closely with CathVision’s Regulatory team, the 4 other members of the System Engineering team, our software team and the R&D teams as well as QA/RA.
You will be part of projects with up to 20 participants, including suppliers in the US and Canada. Projects will mainly focus on updates of software, design, documentations.
In this role we are looking to welcome a team member that is self-motivated and can structure and manage own tasks. You possess good communication and interpersonal skills, while - at the same time - has a structured working method, eye for details and a pragmatic openminded approach.
Furthermore, you have an in depth understanding of the software solution. You are familiar with the regulatory requirements and possess a professional experience in development and realization of new products in an R&D environment.
Maybe you have a background in medical device development and a solid experience from working with the associated documentation in the technical file as well as knowledge and experience with product development in accordance with ISO 13485, ISO 14971, QSR, and MDR.
You:
- Most likely have a bachelor or master’s degree in software or electronic engineering or related technical field.
- Have a good command of spoken and written English
- A good technical understanding of electronics and/or software development.
- You can focus on requirements, risk assessment and general management of DHF/the technical files.
- Experience with design verification and validation.
- You are not afraid to engage in new projects and has an interest in taking the lead role for smaller projects.
- Have a good command of spoken and written English
- You have a good sense of humour and a positive attitude, are open minded with a can-do attitude and a solution-oriented mindset.
Our offer:
We offer flexible hours, and a lot of freedom. We organise social events during the year that ensure you get to know your colleagues and help make CathVision a nice place to work.
Who are we?
CathVision currently have approximately 26 employees, of which most are working with product development. The organization will be expanded further in 2022. We work in an informal environment and value teamwork, self-management, and continuous learning.
Cath Vision expect to get FDA clearance for the first product, the ECGenius System, in 2022.
How?
For further information do reach out to Recruitment Manager, Lise Sønnersgaard, on telephone no. 60 98 13 03 or [email protected] or apply directly here. Due to GDPR, we cannot receive any CVs via e-mail. Interviews are already taking place, so please get in touch or apply at your earliest convenience.
At PharmaRelations we are committed to being an employer of equal opportunities for all and recruitment practices shall be free from discrimination based on race, color, ancestry, national origin, ethnic group identification, age. Religion, material or parental status, physical or mental disability, sex, sexual orientation, gender, gender identification or expression, or genetic information; the perception of one or more of such characteristics; or associated with a person or group with one or more of these actual or perceived characteristics.
Information og data
Denne ledige stilling har jobtypen "Produktspecialist", og befinder sig i kategorien "Kommunikation, marketing, salg".
Arbejdsstedet er beliggende i Kongens Lyngby.
Jobbet er oprettet på vores service den 17.12.2021, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Produktspecialist
- Kongens Lyngby
- Mandag den 28. februar 2022
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