Director, Software Architecture & Engineering

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).
• 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.).

Benefits

We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture.

• Competitive salaries, annual bonus and 401(k)* with company match
• Comprehensive medical, dental, vision coverage effective on start date
• 24/7 Employee Assistance Program
• Free live and on-demand Wellbeing Programs
• Generous Paid Vacation and Sick Time
• Paid Parental Leave and Adoption Assistance*
• 12 Paid Holidays
• On-Site Child Daycare, Café, Fitness Center**

Company Information

We are deeply committed to fostering a respectful, fair, and welcoming workplace for all individuals, perspectives, and lifestyles. We believe in fostering a non-discriminatory, inclusive work environment where everyone feels a sense of belonging, in full compliance with legal standards. Empathy and unity are core to our company culture, empowering employees to contribute fully and flourish.

Equal Opportunity Employer

Olympus considers a variety of factors when determining actual compensation for this position, including level of experience, working location, and relevant education and certifications.