Job Purpose (Role Definition):
The Senior Systems Engineer is technically responsible for both new product development and product sustenance activities. This role ensures the successful delivery of projects that meet business objectives in terms of scope, time, cost, quality, and performance. As a key member of the R&D team, the Senior Systems Engineer will:
* Play a leading role in defining and executing technology roadmaps, and in developing and optimizing engineering processes and tools to support long-term business goals.
* Own the technical architecture, conduct feasibility assessments, and shape the development roadmap for assigned products, ensuring alignment with regulatory and performance requirements.
* Maintain a understanding of emerging technologies, industry standards, and relevant toolsets, and provide strategic input on architectural and technological decisions to ensure competitiveness and sustainability.
Main Duties and Responsibilities:
* Specify and manage system requirements, including facilitation of user workshops.
* Develop and maintain system architecture and design in alignment with user and stakeholder needs.
* Generate engineering documentation suitable for handoff to downstream design and development teams.
* Lead and support engineering governance activities, including Critical Design Reviews (CDRs).
* Collaborate with V&V teams to support verification and validation, including defect triage and issue resolution.
* Attend and contribute to project meetings, providing technical input, risk assessment, and continuous improvement opportunities.
* Share knowledge and technical expertise across project teams and functional areas.
* Monitor and interpret changes in regulatory standards to ensure design compliance with safety and performance criteria.
* Conduct gap analyses against updated medical standards (e.g., IEC
* Perform risk management activities (e.g., FMEA, hazard analysis) in accordance with ISO 14971.
* Mitigate product and project risk through detailed system-level design reviews, early-phase risk analyses, and lean iterative techniques.
* Contribute to the ongoing development and improvement of engineering processes and tools.
* Participate in risk assessment activities to ensure compliant and systematic handling of product field findings within the systems engineering framework.
Management Responsibilities:
None
Experience and Qualifications Required:
Mandatory:
* Bachelor's degree (or equivalent) in a relevant engineering or scientific discipline (e.g., biomedical, mechanical, systems, or electrical engineering).
* Proven analytical and problem-solving skills, particularly in high-reliability, life-supporting systems such as ventilators.
* Demonstrated experience in translating risk management process standards (e.g., ISO into practical and compliant development methodologies for medical devices.
* Proven ability to interpret and apply product-specific standards for basic safety and essential performance (e.g., IEC into robust system design solutions for ventilator platforms.
* Background in core systems engineering disciplines: Requirements Management, Architecture Definition, System Design, Verification, Validation, Assurance, and Release.
* Proficient in requirements engineering and risk analysis techniques across the full device lifecycle.
* Understanding of the end-to-end systems engineering lifecycle, as defined in ISO/IEC/IEEE 15288, within the context of regulated medical product development.
* Comfortable working in cross-functional teams and across diverse projects, with the flexibility to adapt to rapidly evolving development priorities.
Desirable:
* Proven experience working in cross-functional, multi-disciplinary development environments, collaborating across engineering, quality, regulatory, and clinical teams.
* Background in research and development within regulated industries, preferably in the medical device sector under ISO 13485 and IEC 60601 compliance frameworks.
* Solid understanding of real-time control systems, including control theory and practical implementation in embedded platforms.
* Strong communication and collaboration skills, with a demonstrated ability to work effectively within team settings and a genuine enthusiasm for advancing technology.