Key Responsibilities
1. Leadership & Strategy
- Lead, mentor, and develop a team of system software and scripting engineers working on medical devices and associated infrastructure.
- Define the technical roadmap for system-level components, automation, configuration management, and OS hardening in alignment with product, quality, cybersecurity, and regulatory objectives.
- Collaborate closely with global R&D, Systems Engineering, QA/RA, Cybersecurity, IT, and Service to ensure cohesive end-to-end solutions.
2. OS Component (Medical Devices)
- Oversee the development of OS components interfacing with hardware APIs, embedded subsystems, and ensuring seamless integration with system level components
- Ensure robust, reusable OTS / drivers that provide standardized access to hardware and system-level features while supporting safety, reliability, and cybersecurity requirements.
- Drive systematic maintenance and ensure backward compatibility, risk control, and alignment with design controls, change control, and quality processes.
4. Documentation, Standards & Knowledge Sharing
- Ensure comprehensive documentation of system-level components, APIs, scripts, Windows / Linux hardening baselines, GPOs, SCCM deployment configurations, and configuration procedures in accordance with design control and QMS requirements.
- Adhere to Zeiss medical SW development process and ensure the deliverables are in line with the established roadmap.
- Foster a culture of knowledge sharing via design reviews, training, and best-practice guidelines, ensuring cross-functional understanding of system behavior, Windows / Linux security baselines, and deployment processes.
6. Governance, Quality, Compliance & Cybersecurity
- Define and enforce coding, configuration, OS hardening, cybersecurity, and documentation standards aligned with medical device regulations and internal QMS.
- Partner with QA/RA and Cybersecurity to support compliance with relevant standards and regulations (e.g., IEC 62304, ISO 14971, IEC 81001-5-1, ISO 27001, MDR/FDA expectations).
- Responsible for Lifecycle management for OS release across MED portfolio.
Qualifications & Experience
- Bachelor's or master's degree in computer science, Software Engineering, Electrical/Computer Engineering, or related field.
- Significant experience in system-level software development (e.g., C/C++, low-level APIs, OS internals, hardware interaction) and/or scripting (e.g., PowerShell, Bash, Python) in Windows and/or Linux.
- Proven experience leading or managing engineering teams, ideally in a regulated or safety-critical domain (preferably medical devices) including hiring activities.
- Experience working under a Quality Management System and with medical or comparable standards (e.g., IEC 62304, ISO 13485, ISO 14971, IEC 81001-5-1, ISO 27001 or similar).
- Foster a culture to establish efficient troubleshooting of complex system issues, performance optimization, and system hardening.
Key Skills & Competencies
- Strong people leadership, coaching, and cross-functional collaboration skills.
- Deep understanding of Windows & Linux operating systems in medical device domain - networking, security, and system integration in a product context.
- Structured, risk-aware decision making with focus on patient safety, product quality, and regulatory compliance.
- Ability to review technical engagement with strategic planning, prioritization, and stakeholder management.
Collaboration with the PO for low level backlog grooming and delivery to ensure optimum resource planning.
