Software Systems Engineer II (Medical Devices)

Location: Mounds View, Minnesota, United States of America; onsite. Another listed location is Newton, Massachusetts, United States of America.

Salary: USD 93,600–140,400 per year, plus an eligible short-term incentive plan.

Company

hirify.global develops healthcare technologies designed to alleviate pain, restore health, and extend life, including the Affera cardiac mapping and ablation system.

What you will do

• Develop and maintain system and software architecture models using SysML v1/v2.
• Apply MBSE principles to connect system intent with software services, APIs, schemas, modules, and firmware.
• Define interface contracts and allocations across 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 FMEA, interface risk analysis, and process and tooling improvements for MBSE adoption and trace automation.

Requirements

• Bachelor’s degree with at least 2 years of related experience, or a master’s degree with no required related experience.
• Knowledge of medical product development, IEC 62304, ISO 13485, FDA guidance, or relevant regulated industries.
• Programming proficiency in Python, C++, C#, or similar languages.
• Experience with requirements-driven development, traceability, MBSE concepts, and SysML.
• Strong understanding of technical documentation practices.
• Unrestricted U.S. work authorization is required at hire and throughout employment; sponsorship is not available for this role.

Nice to have

• SysML modeling tools and system architecture modeling experience.
• Software and hardware interface definition, allocation, and risk identification.
• Regulated medical-device software development and software risk management.
• Agile development, Git-based version control, technical writing, and cross-functional collaboration.

Culture & Benefits

• Work on medical technologies intended to improve patient outcomes.
• Health, dental, vision, life, disability, and flexible spending benefits for eligible regular employees.
• Paid time off, paid holidays, employee assistance, tuition assistance, and retirement plans.
• 401(k) plan with employer contribution and match, employee stock purchase plan, and incentive plans.