HW Development Engineer (Burgdorf, CH) presso Solutions for self-medication and medical devices - Ypsomed
Solutions for self-medication and medical devices - Ypsomed · Burgdorf, Svizzera · Onsite
- Professional
- Ufficio in Burgdorf
Your main tasks
- Contribute to all phases of medical device development, from architecture concepts to design verification and design transfer
- Design and develop low-power medical embedded systems, with a strong focus on safety, reliability and regulatory compliance (IEC13485, IEC60601, ISO14971 etc.)
- Create and manage hardware requirements, ensuring full traceability through design and testing
- Apply Design for Manufacturing (DfM), Design for Testing (DfT), and broader DfX principles, to ensure efficient and high-quality production
- Collaborate closely with system engineering, risk management as well as software, mechanical and quality teams throughout the development process
- Support regulatory submissions and preparation of technical documentation required for device certification and approval
Your profile
- Degree in Electrical/Biomedical Engineering or related discipline
- At least 3 years of experience in medical product development
- Proficiency with eCAD tools, preferably Altium
- Solid knowledge of IEC60601, EMC standards, and regulatory processes for medical devices
- Familiarity with risk management principles (ISO 14971)
- Familiarity with design control processes within highly regulated fields, ideally the medical sector
- Strong analytical and problem-solving skills
- Team oriented mindset with excellent communication and collaboration skills, ability to work in multidisciplinary teams
