System-Level Architecture: Lead system-level software and firmware architecture, defining core interfaces and communication protocols (APIs, Wireless) 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 (Threat Modeling), define encryption mechanisms, secure communication protocols, Secure Boot, and Secure Firmware Over-The-Air (FOTA) updates.
Support the New Product Introduction (NPI) 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 (PDLC), including Software Requirements Specifications (SRS), Software Design Descriptions (SDD), 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 (FDA Cybersecurity Guidance, EU MDR) and follow the Quality Management System (QMS) processes and international medical device standards (IEC 62304, ISO 14971, IEC 60601).
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 (integrating hardware, software, mechanics, and sensors), experience in the Medical Device industry – Strong Advantage.
Proven hands-on experience in Embedded C/ C++ development for Microcontrollers (MCU).
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 (BLE, Wi-Fi, etc.) – Significant Advantage.
Experience developing test tools, automation, and manufacturing infrastructure (Python, C#, LabVIEW, or similar) – Advantage.
Deep familiarity with medical software development standards: IEC 62304, ISO 14971 (Risk Management), and FDA guidance – Strong Advantage.
