Senior Systems Engineer
Role details
Job location
Tech stack
Job description
The Senior Systems Engineer leads the definition, architecture, and validation of complex medical systems, with a strong emphasis on usability-driven design. This role is accountable for ensuring that systems are safe, effective, and aligned with user needs, clinical workflows, and regulatory requirements. As a senior technical authority, the Senior Systems Engineer drives cross-program alignment, governs critical design decisions, and embeds usability engineering as a core discipline across the product lifecycle to improve patient outcomes, user experience, and product quality.
Your role will include:
- Leads the definition and deployment of systems engineering strategies across projects and programs, ensuring alignment with organizational objectives, industry standards, and best practices
- Acts as a technical authority for system architecture and design, guiding critical decisions and trade-offs across usability, safety, performance, cost, and scalability
- Owns the translation of user, clinical, business, and regulatory needs into system requirements and design specifications, ensuring end-to-end traceability across the product lifecycle
- Drives the integration of usability engineering and human factors principles into system architecture, requirements, and design decisions, including user research and workflow analysis
- Defines and drives system verification, validation, and clinical evaluation strategies, ensuring robust evidence for system performance, safety, and usability
- Ensures compliance with regulatory standards and leads the integration of usability within risk management processes, including identification and mitigation of use-related hazards
- Collaborates across multidisciplinary stakeholders and drives continuous improvement, advancing systems and usability engineering methodologies, tools, and organizational capabilities
Requirements
- Master's or PhD in Systems Engineering, Biomedical Engineering, Human Factors Engineering, or related field
- 10+ years of experience in systems engineering within regulated industries (preferably medical devices) and preferably 5+ years of experience in usability engineering
- Deep expertise in Systems engineering methodologies
- Deep expertise in Usability / human factors engineering
- Deep expertise in Risk management and regulatory compliance
- Proven track record of leading complex system development across full lifecycle
- Strong experience with regulatory standards (IEC 62366, ISO 14971, FDA/MDR)
- Demonstrated ability to influence across functions and lead without direct authority
- Fluency in English.