Director, Software 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

Working Location: Nationwide

Workplace Flexibility: Hybrid

For more than 100 years, Olympus has focused on making people's lives healthier, safer and more fulfilling.

Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives.

Our five Core Values empower us to achieve Our Purpose:

Patient Focus, Integrity, Innovation, Impact and Empathy.

Learn more about Life at Olympus: https://www.olympusamerica.com/careers .

Job Description

The Director of Software Architecture and Engineering is a senior technology leader responsible for defining and executing the architecture and engineering strategy for medical devices, connected health platforms, and regulated healthcare technologies. This role ensures the development of secure, scalable, compliant, and high-quality software systems aligned with global regulatory standards.

This role involves overseeing the development of scalable, secure, and efficient systems, ensuring alignment with regulatory standards and industry best practices. It collaborates with cross-functional teams to drive technology initiatives, act as architecture subject matter expert for architectural design discussions and decisions, drive the decommissioning agenda, optimize infrastructure, and enhance the overall digital transformation strategy.

The ideal candidate brings deep expertise in regulated software development (FDA, ISO, IEC), embedded and cloud-connected systems, cybersecurity, and engineering leadership within medical device or digital health environments.

Job Duties

Technology Strategy & Architecture Vision

• Define and lead the long-term architecture strategy for medical devices and connected health platforms.
• Drive innovation in Software as a Medical Device (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.

Medical Device Software Architecture

• Oversee architecture for:
  • Cloud-connected device platforms
  • Mobile and web applications supporting devices
• Ensure system interoperability (HL7, FHIR, DICOM where applicable).
• Establish secure device-to-cloud communication architectures.
• Define cybersecurity-by-design frameworks aligned with FDA and global guidance.

Regulatory & Compliance Leadership

• Ensure compliance with:
  • FDA 21 CFR Part 820 / Part 11
  • ISO 13485
  • IEC 62304 (Medical Device Software Lifecycle)
  • ISO 14971 (Risk Management)
  • GDPR / HIPAA (as applicable)
• Oversee Design Controls, Verification & Validation (V&V), and documentation processes.
• Lead software risk management and hazard analysis activities.
• Support regulatory submissions (510(k), CE marking, etc.) from a software perspective.

Engineering Execution & Quality

• Lead cross-functional engineering teams (software, firmware, systems, DevOps, QA).
• Implement secure software development lifecycle (SSDLC) practices.
• Establish CI/CD processes suitable for regulated environments.
• Drive system reliability, performance, and traceability across the product lifecycle.
• Oversee technical documentation and audit readiness.

Organizational Leadership & Talent Development

• Build and scale high-performing engineering and architecture teams.
• Mentor engineering leaders and principal architects.
• Establish engineering KPIs aligned with product quality and compliance.
• Foster a culture of accountability, innovation, and regulatory excellence.

Executive & Cross-Functional Collaboration

• Partner with Regulatory Affairs, Quality, Clinical, Product, and Manufacturing teams.
• Translate technical architecture into regulatory and business impact for executives.
• Participate in customer, auditor, and regulatory agency engagements.
• Support M&A technical due diligence when applicable.

Job Quaifications

Required

• Bachelor's or Master's degree in Computer Science, Software Engineering, Biomedical Engineering, Electrical Engineering, or related field.
• Minimum of 12 to 15 years of progressive software engineering experience.
• Minimum of 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.

Preferred

• Experience with Software as a Medical Device (SaMD).
• Familiarity with AI/ML in regulated healthcare products.
• Experience with cybersecurity standards (e.g., FDA cybersecurity guidance, NIST).