HW Development Engineer (Burgdorf, CH) chez Solutions for self-medication and medical devices - Ypsomed

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