Sr. Medical Device System Engineer
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* We are seeking a highly skilled Sr. Medical Device System Engineer to join our team.
About the Role
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* The successful candidate will be responsible for collecting product requirements and translating them into technical specifications.
* This includes managing and ensuring the traceability of all requirements during the development process.
Responsibilities
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* Create system architecture of medical devices together with project teams.
* Define system requirements, identify system components, and define interfaces between components.
* Evaluate risks and develop risk reduction measures according to ISO 14971 standards.
* Collaborate and coordinate in project progress reporting.
Requirements
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* Technical or scientific degree (B.Sc., M.Sc., or equivalent).
* At least 5 years of experience in medical product development.
* Familiarity with regulatory requirements (ISO 13485, FDA, MDR) and processes for developing medical products.
* Strong analytical and problem-solving skills.
* Independent and reliable work style.
* Open and solution-oriented personality.
* Fluent English language skills (min. B2 level).