Director, Software Architecture & Engineering

Olympus Corporation is a medical technology company focused on advancing healthcare technologies and elevating the standard of patient care. The Director of Software Architecture and Engineering will define and execute architecture and engineering strategy for medical devices, connected health platforms, and regulated healthcare technologies, while leading secure, scalable, compliant software development. The role also oversees regulatory compliance, engineering execution, organizational leadership, and cross-functional collaboration.

Responsibilities:

• 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
• 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
• 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
• 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
• 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
• 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

Requirements:

• 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
• 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)
• Knowledge of interoperability standards (HL7, FHIR, DICOM)
• Cloud and/or medical device quality certifications
• Experience in global regulatory environments (FDA, EU MDR, Health Canada, etc.)