We are seeking an experienced software professional to lead the end-to-end development of our software systems, with strong architectural skills and deep familiarity with medical device standards and regulation

Essential duties and responsibilities

• 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).
• Documentation

Must-Have Qualifications

Technical skills:

• 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
• Web development (react/html /JS)- Advantage
• Python and/or MATLAB- Advantage
• Previous experience with products combining HW/SW, having multi-tier architectures – Must
• Experienced in SW development and SW lifecycle methodologies in the Medical Devices arena – Must
• Comfortable developing across Windows / Linux
• Solid understanding of IEC 62304 (Medical device software lifecycle)
• 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)

Personal skills:

• Excellent interpersonal and communication skills
• Managerial skills, Agile/Scrum experience.
• Experienced with cross-functional collaboration, e.g. QA, regulatory, product, and clinical teams
• Task prioritization & planning, Ownership mindset