Medical Device System Architect
vor 2 Wochen
About the Role:
We are seeking a highly skilled Medical Device System Architect to join our team at Hamilton. As a key member of our product development team, you will be responsible for designing and developing medical devices that meet the highest standards of quality and safety.
Key Responsibilities:
- Collect and translate product requirements into technical specifications, ensuring traceability throughout the development process.
- Collaborate with the project team to create the system architecture of medical devices, defining system requirements, identifying components, and defining interfaces.
- Ensure the integration of system components and verify that medical devices function properly.
- Ensure compliance with relevant regulatory requirements, including planning and advisory support for integration and verification activities.
- Collaborate in the development of risk analyses and identify and evaluate risks with specialist departments.
- Regularly exchange and report project progress to the project manager, product manager, and product owner.
Requirements:
- Technical or scientific degree (B.Sc. FH, M.Sc. ETH or equivalent).
- 5+ years of experience in medical product development.
- Solid understanding of regulatory requirements (ISO 13485, FDA, MDR) and processes for developing medical products.
- Strong analytical and systematic problem-solving skills.
- Independent, reliable, and structured way of working.
- Open and solution-oriented personality, enjoying working in interdisciplinary teams.
- Fluent English with the ability to speak German (min. B2 level).
About Hamilton:
Hamilton is a leading manufacturer of intelligent ventilators and a pioneer in the fields of ventilators, automated pipetting, sample management, and process sensors. We are committed to driving innovation to improve people's lives and offer a motivating working environment, various leisure activities, and modern working conditions.
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