Director of SaMD Architecture & Engineering

6AM City, LLC; False Pass (AK); Hybrid; USD 180,000 - 240,000; Full time

Job summary

Olympus is seeking a Director of Software Architecture and Engineering to define and execute the architecture strategy for medical devices, connected health platforms, and regulated healthcare technologies. You will ensure secure, compliant software systems aligned with global regulatory standards.

This role leads cross-functional teams, drives SaMD and cloud initiatives, and partners with regulatory and quality functions to support submissions and ongoing compliance.

Qualifications

• Minimum 12–15 years of progressive software engineering experience.
• Experience leading multidisciplinary engineering teams in medical devices or regulated healthcare tech.
• Deep expertise in IEC 62304-compliant software development.
• Proven track record building secure, scalable, compliant software systems.

Responsibilities

• Define and lead the long-term architecture strategy for medical devices and connected health platforms.
• Drive innovation in SaMD, embedded systems, IoT-enabled devices, and cloud integration.
• Align engineering strategy with product roadmaps, regulatory requirements, and commercialization goals.
• Oversee architecture for cloud-connected device platforms and mobile/web apps supporting devices.
• Establish secure device-to-cloud communication and cybersecurity-by-design frameworks.

Skills

Software architecture leadership

Regulated software development

Cloud architecture (AWS/Azure/GCP)

Regulatory audits & submissions

Embedded/connected devices

Cybersecurity in regulated envs

Education

Bachelor's or Master's degree in Computer Science, Software Engineering, Biomedical Engineering, Electrical Engineering, or related field

Job description

Olympus is seeking a Director of Software Architecture and Engineering to define and execute the architecture strategy for medical devices, connected health platforms, and regulated healthcare technologies. You will ensure secure, compliant software systems aligned with global regulatory standards.

This role leads cross-functional teams, drives SaMD and cloud initiatives, and partners with regulatory and quality functions to support submissions and ongoing compliance.