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Staff Software Systems Engineer
Sin especificarTiempo completoSystems Software DevelopmentMedical Devices
Provide technical leadership across software-intensive medical device systems and guide product direction for Agile teams developing real-time applications. Partner with systems engineering and cross-functional stakeholders to deliver compliant, maintainable product solutions.
Responsabilidades
- Lead feature definition with software, systems, human factors, clinical engineering, and other stakeholders.
- Set product vision and priorities based on strategy, customer needs, clinical workflows, and technical roadmaps.
- Turn roadmap features into requirements, user stories, and acceptance criteria.
- Decompose system requirements and architecture into software requirements, interfaces, implementation strategies, traceability, and verification approaches.
- Identify, assess, communicate, and manage technical and integration risks; support root-cause analysis and solution development.
- Review software designs for alignment with system intent, requirements, cybersecurity, and quality objectives.
- Guide technical decisions through requirements analysis, architecture decomposition, risk assessment, stakeholder input, and evaluation of design alternatives.
- Support hardware/software integration and ensure work meets quality and compliance requirements.
- Provide technical leadership and mentorship across engineering disciplines.
Requisitos
- Bachelor’s degree in engineering, computer science, or a related discipline.
- At least 8 years of software engineering design and development or systems engineering experience.
- Expertise in C++ and object-oriented software development in complex systems.
- Experience defining software architecture, evaluating technical tradeoffs, and translating system requirements and architecture into software requirements, interfaces, and designs.
- Experience as a Product Owner or Product Manager in an Agile environment, with knowledge of Scrum, SAFe, or related methods.
- Strong verbal and written communication skills.
Se valora
- Master’s degree in engineering or computer science.
- Experience with medical-device standards and regulations, including IEC 62304, ISO 14971, FDA quality regulations, and cybersecurity guidance.
- Experience with cardiac mapping or ablation systems, medical imaging, image processing, or image-guided therapy.
- Knowledge of FDA cybersecurity guidance and GDPR.
- Experience with complex electromechanical systems, including hardware, embedded firmware, and disposables.
- Demonstrated technical leadership and mentorship.