Software Systems Engineer II

Can you please confirm your top 3 skills sets required?

• • Model-Based Systems Engineering (MBSE) and system architecture modeling
  • Requirements development and bidirectional V-model traceability
  • Software and hardware interface definition, allocation, and risk identification

What is your target years of experience?2- 10+ years - Can re level as needed based on candidate

• Must have:
  • Experience with complex medical devices or a related industry
  • Good knowledge of both hardware and software
  • Architecture/design knowledge
  • Understanding of runtime software behavior, such as processes, threads, and resource trade-offs (CPU, memory, timing)
  • Knowledge of software development processes (e.g., IEC 62304)
  • Software risk analysis experience
• Strong plus: MBSE experience (SysML preferred)
• Nice to have: Software development or scripting experience

Main responsibilities:

• Develop system/software architecture models and define hardware/software interfaces
• Write requirements and maintain V-model traceability
• Perform software and interface risk analysis (e.g., FMEA)

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Job Description

The Software Systems Engineer II will an integral member in the Software Team, working on cutting-edge technology in the electrophysiology field. This role offers a rare chance to be at the forefront of helping develop a groundbreaking technology that can disrupt the industry.

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