The Role:The Principal Software Engineer leads the architecture and technical direction for the next-generation ReActiv8 Class III active implantable medical device. The individual serves as the technical lead of the software engineering team, establishing architecture frameworks, driving design decisions, and owning platform strategy - all within the regulatory and quality requirements of a PMA-class implantable device. Strong systems thinking, hands-on software architecture experience in safety-critical environments, and the ability to align clinical, regulatory, and business requirements into scalable, maintainable solutions are essential.
Position Responsibilities: - Lead the architecture and technical evolution of the ReActiv8 system across embedded firmware, mobile, web application, and cloud infrastructure.
- Define and maintain software architecture strategies including component decomposition, interface contracts, data flow, and integration patterns across the full system stack.
- Translate clinical user needs, regulatory requirements, and business objectives into scalable, maintainable software designs compliant with IEC 62304 and FDA PMA expectations.
- Establish and enforce architecture frameworks, design principles, coding standards, and technical conventions for the software team.
- Lead architecture reviews, technical risk assessments, and design control activities including requirements traceability, hazard analysis contributions, and verification strategy.
- Drive Agile/SCRUM ceremonies and technical decision-making as the engineering team's technical leader; collaborate with Product, Quality, and Regulatory.
- Maintain and evolve tools and development practices: Azure DevOps, Git, Figma, and Claude Code for AI-assisted development workflows in a regulated software context.
- Mentor and provide hands-on technical guidance to software engineers across firmware, application, and cloud domains.
- Support FDA regulatory submissions and design documentation; participate in internal/external audits and regulatory inspections.
- Ensure cybersecurity principles are incorporated throughout the system architecture in line with FDA guidance for connected and implantable devices.
Qualifications:- Bachelor's degree in Computer Science, Computer Engineering, or equivalent.
- 15+ years of software engineering in product development; 8+ years in regulated medical device environments.
- Demonstrated experience with IEC 62304 software development lifecycle, with Class III implantable or other safety-critical device experience strongly preferred.
- Direct experience supporting FDA PMA or 510(k) submissions and design control documentation.
- Proficiency in .NET, C#, Blazor, and .NET MAUI - the core technology stack for the ReActiv8 clinician programmer and patient mobile application.
- Experience with EF Core and SQLite for data persistence.
- Hands-on experience with Azure services for connected medical device ecosystems.
- Proficiency with Azure DevOps and Git for CI/CD pipeline management and source control in a regulated environment.
- Experience in embedded firmware development and cross-domain system integration (firmware ↔ mobile ↔ cloud).
- Familiarity with Figma for UX design collaboration and design review in a cross-functional team.
- Experience with Bluetooth and wireless connectivity protocols relevant to implantable device communication.
- Familiarity with gRPC for service communication within cloud or device-connected architectures.
- Experience leading software teams in an Agile/SCRUM framework as a technical lead or principal-level engineer.
- Strong cybersecurity background aligned with FDA guidance for connected implantable devices.
- Excellent communication and stakeholder management skills; able to translate complex technical concepts for clinical, regulatory, and executive audiences.
The salary range for this position is $190,000 to $210,000/year; however, base pay offered will take into account a range of factors, including job-related knowledge, skills, and experience. The total compensation package includes a range of medical, dental, vision, financial, and other benefits, as well as equity.
