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Software and Firmware Engineering Manager
Not specifiedFull-timeEngineering ManagementMedical Devices
Lead software and firmware architecture, hands-on embedded development, cybersecurity, and Agile delivery for multidisciplinary systems. Work closely with verification, hardware, mechanical, and quality and regulatory teams.
Responsibilities
- Lead system-level software and firmware architecture, defining interfaces and communication protocols between devices, mobile applications, and testing and manufacturing tools.
- Design embedded firmware hands-on.
- Lead product cybersecurity strategy and implementation, including risk assessments, encryption, secure communications, Secure Boot, and secure firmware over-the-air updates.
- Develop and maintain testing infrastructure and production jigs to support new product introduction; troubleshoot software and firmware issues on the production line.
- Write, review, and approve software regulatory documentation throughout the product development lifecycle, including requirements, design descriptions, traceability matrices, and integration reports.
- Plan and deliver software projects using Agile methods, managing tasks, milestones, schedules, and resources in alignment with the R&D roadmap.
- Provide technical leadership, mentorship, and hands-on troubleshooting support.
- Ensure alignment with applicable cybersecurity regulations, quality processes, and medical-device standards, including FDA guidance, EU MDR, IEC 62304, ISO 14971, and IEC 60601.
- Collaborate with software verification and validation, hardware, mechanical, and quality and regulatory teams.
Requirements
- Bachelor’s degree in Software Engineering or Computer Science.
- At least 10 years of software and firmware development experience for multidisciplinary systems integrating hardware, software, mechanics, and sensors.
- Hands-on embedded C/C++ development experience with microcontrollers.
- Experience with medical-device cybersecurity standards and leading embedded or medical-device cybersecurity initiatives, including threat modeling, encryption, and secure architecture.
- Strong experience producing detailed engineering and development documentation.
Nice to have
- Medical device industry experience.
- Team Lead or Tech Lead experience managing engineers.
- Experience developing mobile applications and wireless protocols such as BLE or Wi-Fi.
- Experience building test tools, automation, or manufacturing infrastructure using Python, C#, LabVIEW, or similar.
- Familiarity with IEC 62304, ISO 14971, and FDA guidance.