Responsibility: Lead the end-to-end development of medical sensors, including 3D modeling, design documentation, DFMEA, and requirements management. Create and maintain comprehensive product documentation such as 2D/3D production drawings, specifications, test protocols, technical reports, and design verification records. Conduct and lead design reviews, ensuring alignment with cross-functional project teams and key stakeholders. Collaborate with suppliers to qualify components and materials, ensuring high standards of quality, reliability, and compliance. Support risk assessments, including process and design FMEAs. Perform feasibility studies and implement improvements in manufacturing processes to enhance product quality and efficiency. Contribute to continuous improvement and innovation initiatives within the R&D organization. Ensure compliance with relevant regulatory standards and medical device quality systems.
Background: Master’s degree in Mechanical Engineering, Electrical Engineering, or a closely related discipline. Minimum of 3 years of professional experience in product design, preferably within the medical device industry. Proven experience in design for manufacturing (DFM) and working within regulated environments. Solid understanding of medical quality systems and standards (e.g., ISO 13485). Strong communication skills in English (C1 level), with the ability to work effectively across global teams. Proficiency in CAD tools for 3D modeling and drawing development. Background in biocompatibility for surface-contact medical devices. Experience working in the mechatronics or sensor technology industry. Certification in Design for Six Sigma (DFSS) or similar methodologies.