- מיקום
- כל הארץ
- היקף משרה
- משרה מלאה
- תפקיד
- מהנדס/ת חומרה ואלקטרוניקה
תיאור המשרה
- System-Level Architecture: Lead system-level software and firmware architecture, defining core interfaces and communication protocols %28APIs, Wireless%29 between the device, mobile app, and test/manufacturing tools.
- Firmware Engineering: Hands-on embedded firmware design.
- Cybersecurity: Lead the cybersecurity strategy and implementation across all company products following a Secure by Design approach. Perform cybersecurity risk assessments %28Threat Modeling%29, define encryption mechanisms, secure communication protocols, Secure Boot, and Secure Firmware Over-The-Air %28FOTA%29 updates.
- Support the New Product Introduction %28NPI%29 process by developing and maintaining testing infrastructure and production jigs.
- Provide ongoing technical support for software/firmware issues arising on the production line.
- Write, review, and approve regulatory software documentation throughout the Product Development Life Cycle %28PDLC%29, including Software Requirements Specifications %28SRS%29, Software Design Descriptions %28SDD%29, Traceability Matrices, and Integration Reports.
- Agile Project Management: Lead software projects using Agile methodologies—plan, track, and execute day-to-day tasks, milestones, project schedules, and resource allocation aligned with the overall R&D roadmap.
- Provide technical leadership, professional mentoring, and hands-on troubleshooting support for complex technical challenges.
- Ensure full alignment with international Cybersecurity regulations and guidelines %28FDA Cybersecurity Guidance, EU MDR%29 and follow the Quality Management System %28QMS%29 processes and international medical device standards %28IEC 62304, ISO 14971, IEC 60601%29.
- Work closely with Software V&V, Hardware, Mechanical, and QA/RA teams.
Requirements
- B.Sc. in Software Engineering / Computer Science
- 10+ years of experience in software and firmware development for multidisciplinary systems %28integrating hardware, software, mechanics, and sensors%29, experience in the Medical Device industry – Strong Advantage.
- Proven hands-on experience in Embedded C/ C++ development for Microcontrollers %28MCU%29.
- Experience with cybersecurity regulatory standards for medical devices, leading Cybersecurity initiatives in embedded or medical device environments %28Threat Modeling, encryption, secure architecture%29.
- Strong background in writing in-depth engineering and development documentation.
- Team Lead or Tech Lead experience managing engineers – Advantage.
- Experience in development and integration of mobile applications/ wireless communication protocols %28BLE, Wi-Fi, etc.%29 – Significant Advantage.
- Experience developing test tools, automation, and manufacturing infrastructure %28Python, C#, LabVIEW, or similar%29 – Advantage.
- Deep familiarity with medical software development standards: IEC 62304, ISO 14971 %28Risk Management%29, and FDA guidance – Strong Advantage.
