Principal Software Engineer

Responsibilities:

IEC 62304 Compliance and Documentation

• Assess software against IEC 62304 requirements; define software safety classifications and perform gap analyses.
• Author and own the Software Development Plan (SDP), establishing development methodology, configuration management, version control, review, and release processes.
• Create and maintain the Software Requirements Specification (SRS), Software Architecture Description (SAD), and software-level DFMEA in accordance with design controls.
• Develop and maintain requirements-to-implementation traceability across the software lifecycle.
• Partner with Regulatory Affairs and Quality teams to ensure software documentation meets global submission requirements.
• Serve as the subject matter expert for software lifecycle compliance and design control activities.

Risk, Test, and Verification Leadership

• Own software risk management activities per ISO 14971 and IEC 62304, including hazard analysis, DFMEA, and risk control implementation.
• Define and maintain Software Verification and Validation Plans.
• Establish traceability between requirements, test protocols, and objective evidence.
• Lead the review of software test strategies across unit, integration, and system-level verification activities.
• Guide defect management, regression testing, and software release qualification processes.
• Collaborate with Safety and Human Factors teams to ensure use-related software risks are identified and mitigated.

Technical Leadership and Software Architecture

• Define software architecture and technical roadmaps supporting future indications and product evolution.
• Lead critical technical decisions regarding software design, scalability, maintainability, and cybersecurity.
• Collaborate with Therapy Physics, Systems Engineering, Clinical, and Product Development teams to translate clinical and system requirements into software specifications.
• Define appropriate technology stacks and development frameworks for treatment planning and therapy delivery software.
• Evaluate new technologies, tools, and development methodologies to improve product quality and team effectiveness.
• Provide technical mentorship and guidance to software engineers and cross-functional stakeholders.

Project and Program Leadership

• Own software project plans, technical milestones, and deliverables aligned with overall program objectives.
• Identify technical risks, dependencies, and mitigation strategies.
• Coordinate activities with external software vendors and development partners, ensuring design control and DHF-compliant outputs.
• Communicate technical progress, risks, and recommendations to program leadership and executive stakeholders.

Qualifications Required:

• 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 software development lifecycle processes for medical devices.
• Demonstrated 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 per ISO 14971.
• Proven 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).
• Project leadership experience managing technical deliverables in complex, cross-functional environments.
• Excellent written and verbal communication skills with the ability to produce regulatory-quality documentation and influence technical decisions across the organization.

Qualifications Preferred:

• 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++ within 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.
• Demonstrated success serving as a technical lead, architect, or principal engineer on complex multidisciplinary product development programs.