Overview In this role you lead the architecture and engineering strategy for medical devices and connected health platforms, ensuring secure, scalable, and compliant software aligned with global standards. You will partner with cross-functional teams to drive digital transformation and regulate software development within a medical context. You will shape SaMD and embedded/cloud-connected systems, balancing innovation with regulatory excellence. This is a high-impact opportunity to influence patient care through robust software infrastructure.
Compensation / Benefits- Competitive salaries
- Annual bonus
- 401(k) with company match
- Medical, dental, vision coverage
- Paid vacation and sick leave
- Paid parental leave
Responsibilities- Define and drive long-term architecture strategy for medical devices and connected health platforms
- Lead innovation in SaMD, embedded systems, IoT-enabled devices, and cloud integration
- Align engineering strategy with product roadmaps, regulatory requirements, and commercialization goals
- Evaluate emerging technologies in digital health, remote monitoring, AI/ML-enabled diagnostics, and edge computing
- Oversee architecture for cloud-connected device platforms, mobile/web apps, and ensure interoperability (HL7, FHIR, DICOM)
- Establish secure device-to-cloud communication architectures and cybersecurity-by-design frameworks
- Ensure compliance with FDA 21 CFR Part 820/11, ISO 13485, IEC 62304, ISO 14971, GDPR/HIPAA as applicable
- Lead software risk management, V&V, and regulatory submissions from a software perspective
- Lead cross-functional engineering teams, implement SSDLC, CI/CD for regulated environments
- Drive system reliability, performance, and lifecycle traceability; oversee technical documentation and audit readiness
- Build and scale engineering teams; mentor leaders; define engineering KPIs in line with compliance
- Collaborate with Regulatory Affairs, Quality, Clinical, Product, and Manufacturing; support audits and due diligence
Key requirements- Bachelor's or Master's degree in related fields
- 12-15 years of progressive software engineering experience
- 5 years in senior leadership roles in medical devices or regulated healthcare technology
- Deep expertise in IEC 62304-compliant software development
- Experience with connected medical devices
- Strong understanding of cloud architecture (AWS, Azure, or GCP)
- Proven experience supporting regulatory audits and submissions
- Experience leading multidisciplinary engineering teams
- leadership and people development
- cross-functional collaboration
- regulatory and risk communication
- IEC 62304
- SaMD
- cloud architecture (AWS/Azure/GCP)
