Principal Consultant – Medical Device Software Architecture

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Principal Consultant – Medical Device Software Architecture & User Experience
Location: Remote; Irvine, CA - Hybrid 3 days onsite
Duration: October. 2026 – October 2028 (tentative)
Expected Hours: 40 hours weekly
No third parties. We are engaging directly with candidates only.
Job Description:
We are seeking a highly experienced software consultant to provide strategic and technical leadership for the development of a next-generation user experience on an advanced cardiovascular therapy platform.
This individual will conduct an independent assessment of our current software architecture, user interface strategy, development processes, and contractor ecosystem, and provide recommendations to help establish a best-in-class procedural user experience. The consultant will work closely with Clinical Development, R&D, Human Factors, Marketing, and software development teams, as well as existing software contractors, to guide software and UI development efforts from concept through design commercialization.
This is a high-impact advisory and hands-on leadership role that requires deep expertise in medical device software, human-centered design and system architecture.
Key Responsibilities
Strategic Assessment & Gap Analysis
Evaluate the current software architecture, system design, user interface framework, and development processes.
Identify strengths, risks, technical debt, organizational gaps, and scalability concerns.
Assess the effectiveness of current software development resources, contractors, and operating models.
Provide an independent view of what is required to deliver a world-class clinical user experience.
User Experience & Leadership
Assess procedural workflows and user journeys from system setup through completion of a clinical procedure.
Provide recommendations on navigation architecture, information hierarchy, workflow optimization, and usability.
Guide development of intuitive, efficient, and clinically relevant user experiences for physicians and supporting staff.
Ensure software design supports safe and effective use in high-pressure procedural environments.
Software Architecture & Technical Guidance
Review application architecture, software frameworks, integration strategies, and development practices.
Assess maintainability, scalability, extensibility, and long-term supportability of the software platform.
Provide guidance on best practices for software development in regulated medical device environments.
Mentor and provide architectural direction to existing software development contractors and engineering teams.
Data Management & Automation
Assess existing approaches for system logging, event tracking, and operational data capture.
Provide recommendations regarding log file architecture, troubleshooting tools, and supportability.
Evaluate workflows related to data import, export, reporting, automation, and future analytics capabilities.
Identify opportunities to improve workflow efficiency through automation and streamlined data management.
Organizational & Resource Planning
Recommend the organizational capabilities required to support future software development.
Define critical skill sets, roles, and responsibilities needed for sustained success.
Advise on the optimal balance of internal resources, consulting support, and outsourced development.
Provide a roadmap for building a high-performing software and UX organization.
Required Qualifications
15+ years of software development experience in medical devices, healthcare technology, or other highly regulated industries.
Demonstrated experience leading software architecture and user interface development for medical device capital equipment.
Experience developing software for Class II and/or Class III medical devices.
Strong understanding of software development lifecycle processes within regulated environments.
Expertise in software architecture, system integration, and user interface development.
Experience applying Human Factors Engineering principles to complex medical workflows.
Knowledge 62304, IEC of IEC 62366, FDA Human Factors Guidance, and related medical device software standards.
Proven ability to influence cross-functional teams and drive alignment among diverse stakeholders.
Excellent communication and executive presentation skills.
Preferred Qualifications
Experience with complex medical devices, including structural heart, transcatheter, electrophysiology, robotic surgery, or imaging platforms.
Expertise in software architecture, system integration, UI/UX design, and real-time data visualization.
Experience in regulated environments, including software V&V and medical device standards.
Knowledge of device connectivity, data management, reporting, and workflow automation.
Ability to translate clinical workflows into intuitive user experiences.
Experience leading cross-functional teams and collaborating with UX, design, engineering, and clinical stakeholders.
Eligibility Requirements:
Must be legally authorized to work in the United States.
As a contractor, including remote contractors, you may be required to complete a background check.
As a contractor, you will be paid for the time you work; this does not include paid time off (PTO) or holidays. If you participate in our Payroll Services (W2) engagement, you may be eligible for Paid Sick Leave (PSL), depending on your work location and state-specific regulations.

Work arrangement
Yes