The ideal candidate has strong MBSE skills and experience using SysML (v1/v2) to support V-model traceability from requirements through verification. They will own key features, collaborate across engineering teams, and are enthusiastic about making a meaningful difference for millions.
About the Mapping and Ablation System
The Mapping and Ablation System is an innovative medical technology designed to treat patients with cardiac arrhythmias. The system involves advanced mapping techniques to create detailed images of the heart’s electrical activity, helping physicians identify abnormal areas causing arrhythmias. Once identified, the Ablation System delivers targeted energy to disrupt these abnormal signals, restoring normal heart rhythm.
Top Skills Required
Model-Based Systems Engineering (MBSE) and system architecture modeling
SysML v1/v2 proficiency and associated modeling tools
Requirements development and bidirectional V-model traceability
Software and hardware interface definition, allocation, and risk identification
Regulated medical-device software development, including IEC 62304, ISO 13485, and FDA guidance
Software risk management and FMEA
Programming proficiency in Python, C++, C#, or similar languages
Technical documentation and report writing
Cross-functional collaboration and clear written and verbal communication
Agile development, Git-based version control, and process/tooling improvement
Primary Responsibilities
Develop and maintain system and software architecture models using SysML (v1/v2).
Apply MBSE principles to connect system intent to software services, APIs, schemas, modules, and firmware.
Define interface contracts and allocations between system functions, software, and hardware components.
Support V-model traceability across requirements, design, implementation, and verification
Author and review software system requirements with full bidirectional traceability.
Perform risk analysis activities including FMEA and interface risk identification.
Contribute to process and tooling improvements for MBSE adoption and trace automation.
Apply the appropriate standards, processes, procedures, and tools throughout the system development life cycle.
Required Qualifications
Knowledge of Medical Product development, IEC-62304, ISO 13485, and FDA guidance in a technical discipline, preferably software related
Bachelor’s degree in engineering (Software Engineering, Computer Science, Computer Engineering or related technical field) with a minimum of 2 years of experience, or master’s degree plus 0 years related experience.
Proficient in programming languages such as Python, C++/C# or similar languages
Experience with requirements-driven development and traceability.
Familiarity with MBSE concepts and SysML.
Strong understanding of good documentation practices
Preferred Qualifications
Experience with SysML v2 tooling.
Experience writing technical reports
Experience with QT/QML
Experience with software version control systems, such as Git
Experience with Agile development
Strong work ethic and entrepreneurial drive
Ability to work effectively in a fast-paced, collaborative environment.
Strong communication skills, both written and verbal