Software Lead - Medical Devices
- תל אביב
- משרה קבועה
- משרה מלאה
- Leading and managing the entire software lifecycle
- Software architecture & design
- Hands-on implementation, coding
- Planning, managing and working under all relevant regulatory requirements and constraints, e.g. IEC 62304 (SW lifecycle requirements, medical devices).
- B.Sc., Computer Science / SW engineering - Must
- M.Sc., Computer Science / SW engineering - Advantage
- At least 8 years of experience in SW development
- A minimum of 4 years in architectural roles
- Strong software development knowledge, C# and C++
- Experienced with embedded systems, real-time OS
- Familiarity with firmware / software interfaces and hardware integration
- Previous experience with HW & SW products, with multi-tier architecture
- Experienced in SW development and SW lifecycle methodologies in the Medical Devices arena
- Comfortable with both Windows & Linux
- Solid understanding of IEC 62304 (Medical device software lifecycle)
- Python and / or MATLAB
- Familiarity with ISO 13485, ISO 14971 (risk management), FDA 21 CFR Part 820
- Understanding of SOUP (Software of Unknown Provenance) handling
- Awareness of cybersecurity and data privacy (e.g., HIPAA/GDPR if applicable)
- Web development (react/html /JS)
- Excellent interpersonal and communication skills
- Managerial skills
- Working in an Agile / Scrum environment
- Experience working in a cross-functional collaborating company (QA, Regulation, Product and clinical)
- Task prioritization & planning
- Ownership & self-starter mindset
Mploy