Principal Systems Architect – Medical Device Interoperability

Becton Dickinson Medical Devices•San Diego, CA

14h•Onsite

About The Position

Software Systems Architect responsible for leading architecture of interoperable medical device ecosystems across embedded devices, connectivity platforms, and healthcare systems. Drives design of scalable, secure device-to-cloud and system-to-system integrations using standards such as HL7 and IHE. Provides deep technical leadership across embedded (RTOS), connectivity, and cloud architectures, ensuring cohesive and reliable end-to-end solutions. Partners with cross-functional teams to ensure compliance with regulatory, cybersecurity, and safety requirements while supporting verification and validation strategies. Influences product direction, industry standards, and innovation to advance interoperability and improve clinical outcomes. Job Description We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us. Role Summary The Medication Management Solutions (MMS) organization at BD is seeking a Principal-level Software Systems Architect to define and drive the end-to-end system architecture for interoperable, AI-enabled medical device ecosystems. This role operates at a system-of-systems level, spanning embedded bedside devices, connectivity platforms, cloud services, analytics pipelines, and integrations with healthcare information systems within the Internet of Medical Devices (IoMD). The architect will own architectural strategy, system decomposition, interface contracts, and cross-domain design decisions that ensure scalable, secure, and clinically safe interoperability. The role requires deep experience in embedded systems, connectivity, cloud-native architectures, and increasing use of data and AI capabilities to improve clinical workflows, system observability, and patient safety, while operating within regulated medical device constraints. Principal Objective Define, govern, and evolve system architecture across multiple product platforms to deliver robust, scalable, compliant, and future-ready interoperability solutions that align with business objectives, clinical workflows, regulatory expectations, and emerging AI-driven capabilities.

Requirements

Technical Leadership Proven experience leading architecture for large-scale, distributed, system-of-systems solutions in regulated domains.
Strong systems thinking with the ability to reason across devices, software, data, users, and clinical workflows.
Experience guiding architectural decisions across the full product lifecycle, including regulatory submission and post-market evolution.
Excellent written and verbal communication skills with the ability to influence without authority.
Technical Expertise Deep expertise in system and software architecture, architectural patterns, and domain-driven design.
Strong experience with embedded RTOS-based systems integrated into enterprise and cloud ecosystems.
Experience with interoperability standards including HL7, IHE, FHIR, JSON, and XML.
Programming experience in C, C++, Python, JavaScript, or similar languages.
Understanding of requirements engineering, hazard analysis, and risk management.
Hands-on or architectural experience with AI, analytics, or data platforms in regulated or safety-critical systems.
Knowledge of cybersecurity frameworks such as NIST, OWASP, MITRE, and FIPS.
Experience working in Agile or hybrid development environments.
Bachelor’s or Master’s degree in Computer Science, Engineering, Biomedical Engineering, or related field.
15+ years of experience in software, systems, or integration architecture, with demonstrated leadership in healthcare or medical device interoperability.

Responsibilities

Define, govern, and evolve system architecture across multiple product platforms to deliver robust, scalable, compliant, and future-ready interoperability solutions that align with business objectives, clinical workflows, regulatory expectations, and emerging AI-driven capabilities.
Define and lead end-to-end system architecture across embedded devices, connectivity layers, cloud services, analytics platforms, and healthcare integrations.
Decompose complex systems into domains, services, and works with clear architectural ownership, responsibilities, and lifecycle boundaries.
Define interface contracts, data models, and message flows using industry standards such as HL7, IHE, FHIR, JSON, and XML.
Ensure architectural consistency and reuse across platforms while supporting product-specific constraints and regulatory contexts.
Drive architectural tradeoff decisions balancing safety, performance, scalability, maintainability, and regulatory risk.
Provide architectural leadership across RTOS-based embedded systems running on ARM platforms.
Define cohesive device, edge, and cloud interaction models, including buffering, resilience, fault handling, and offline behavior.
Architect cloud-based solutions using Azure and AWS, including event-driven, service-oriented, and data pipeline architectures.
Guide technology selection and evolution while ensuring backward compatibility and long-term maintainability.
Define system architectures that enable AI and advanced analytics across interoperability data, device telemetry, alarms, and clinical workflow signals.
Guide integration of machine learning and rule-based analytics for use cases such as clinical safety monitoring, alert analysis, workflow optimization, anomaly detection, and system observability.
Ensure AI-enabled capabilities adhere to explainability, traceability, validation, and risk management expectations appropriate for regulated medical devices.
Partner with data science teams to define data quality requirements, labeling strategies, model lifecycle management, and deployment boundaries (edge vs cloud).
Define governance patterns for AI features, including versioning, monitoring, bias evaluation, and post-market surveillance.
Define cybersecurity architecture aligned with NIST, ISO/IEC 27001, FIPS, HIPAA, and FDA guidance.
Ensure security, safety, and risk controls are architecturally embedded across device, network, cloud, and AI components.
Maintain compliance with medical device standards including IEC 60601, IEC 62304, ISO 13485, ISO 14971, IHE profiles, and FDA expectations.
Ensure architectural designs support regulatory submissions, audits, and post-market organizational change.
Ensure system architecture supports verification, validation, and traceability across all architectural layers.
Partner with system and test architects to define scalable test strategies, simulators, and interoperability validation tools.
Support development of system-level test environments that realistically model hospital workflows and integration scenarios.
Drive continuous architecture improvement based on field feedback, quality data, and post-market insights.
Represent BD as a technical leader in standards organizations such as IHE, HL7, and AAMI.
Influence industry direction for interoperability, device connectivity, and emerging AI-enabled healthcare workflows.
Identify and incubate new architectural capabilities that provide competitive differentiation.
Contribute to intellectual property related to system architecture, interoperability, and AI-driven healthcare solutions.
Provide technical leadership across engineering, quality, clinical, cybersecurity, and product teams.
Mentor senior engineers and architects, strengthening system thinking and architectural rigor across the organization.
Communicate architectural concepts, options, and tradeoffs clearly to both executive and technical audiences.
Align stakeholders around architecture decisions that balance near-term delivery with long-term platform strategy.