Principal Software Engineer (Medical Devices)

Location: Hybrid in Plymouth, Minnesota, United States; U.S. work authorization required. Visa sponsorship is not available.

Salary: $150,000–$175,000 annually.

Company

hirify.global is a commercial-stage medtech company developing the Edison® System, a non-invasive histotripsy therapy platform for liver tumors and future clinical indications.

What you will do

• Lead software development and regulatory compliance for emerging clinical applications from first-in-human studies through commercialization.
• Assess software against IEC 62304, define safety classifications, perform gap analyses, and own software lifecycle compliance.
• Author and maintain the Software Development Plan, Software Requirements Specification, Software Architecture Description, DFMEA, traceability, and verification documentation.
• Lead software risk management, verification and validation planning, test strategy reviews, defect management, regression testing, and release qualification.
• Define software architecture, technical roadmaps, technology stacks, and development frameworks for treatment planning and therapy delivery software.
• Coordinate technical milestones, external software partners, cross-functional stakeholders, and executive communications.

Requirements

• Bachelor’s degree in Software Engineering, Computer Science, Electrical Engineering, or a related field.
• 10+ years of software development experience, including at least 5 years developing software for regulated medical devices.
• Deep expertise in IEC 62304 and medical-device software development lifecycle processes.
• Hands-on experience authoring software compliance documentation, including SDP, SRS, software architecture descriptions, DFMEA, traceability matrices, and verification documentation.
• Direct experience with software risk management under ISO 14971.
• Experience leading software verification and validation activities across complex systems.
• Strong software architecture and system design expertise.
• Experience integrating AI tools into DevOps, Git, and Relyence or similar tools.
• Project leadership experience managing technical deliverables in complex, cross-functional environments.
• Excellent written and verbal communication skills, including the ability to produce regulatory-quality documentation and influence technical decisions.

Nice to have

• Experience building medical-device software processes from early-stage development through commercialization.
• Background in capital equipment, surgical, interventional, or image-guided therapy systems.
• Experience developing software in Python, C, and/or C++ in a regulated environment.
• Familiarity with real-time and embedded software architectures.
• Experience supporting FDA, EU MDR, and other global regulatory submissions for software-enabled medical devices.
• Experience serving as a technical lead, architect, or principal engineer on complex multidisciplinary product development programs.

Culture & Benefits

• Comprehensive benefits package for full-time employees.
• Health, dental, and vision insurance.
• Life, short-term disability, and long-term disability insurance.
• 401(k) and paid time off.
• Equal opportunity workplace that values diversity.