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The Medication Management Solutions (MMS), abusiness unit of BD, has a passion and commitment to help enhance the safety and efficiency of clinician's care delivery process through the use of infusion pump systems.  We are currently seeking a highly skilled Software Systems Architect to join our dynamic team, focusing on the interoperability of bedside medical devices with the broader healthcare information systems, within the Internet of Medical Devices (IoMD). This role entails analyzing and designing architecture for embedded devices and broader IoT ecosystems, ensuring the evolution of healthcare at the bedside and throughout healthcare information systems. The ideal candidate will possess a strong background in embedded device architectures, cloud architectures and technologies, system analysis, domain-driven design, and familiarity with relevant healthcare standards and regulations.

Principal Objective:

Provide technical vision and leadership across various product development teams to develop robust, sustainable, and competitive medical devices and IoT solutions that align with internal and third-party customer expectations.

Key Responsibilities:

Architecture Design and Implementation:

• Distill both functional requirements and architectural characteristics from partners and translate them into scalable and robust architectural solutions.

• Develop domain-driven designs for various user domains, ensuring alignment with user, business, and technical needs.

• Lead the architecture and design of interoperable systems of medical devices with healthcare information systems.

• Provide feedback and guidance to multiple development teams and collaborators

Embedded and Cloud Technologies:

• Guide embedded device architectures, specifically with real time operating systems on ARM.

• Architect and develop cloud-based solutions using technology stacks such as Azure and AWS.

• Develop and prototype using programming languages including C, C++, JavaScript, Python, HL7 or similar.

Cybersecurity:

• Ensure robust cybersecurity measures are in place, adhering to standards such as NIST, ISO/IEC 27001, FIPS, and HIPAA or similar.

• Know the latest emerging cybersecurity threats and technologies to ensure the protection of patient data and device integrity.

• Implement security standard processes across the entire IoT ecosystem, from device to cloud.

Standards and Compliance:

• Ensure compliance with healthcare standards and regulations, including IEC, FDA, AAMI, ISO, and IHE.

• Participate in standardization committees and contribute to the development of new standards and guidelines.

• Maintain up-to-date knowledge of interoperability, architecture, and product development standards within the healthcare industry.

Continuous Quality Improvement:

• Implement and refine processes for both development and quality assurance, promoting a culture of continuous improvement.

• Lead and mentor teams in adopting standard processes for software development, testing, and deployment.

Research and Innovation:

• Drive research and innovation within the organization, fostering a culture of creativity and experimentation.

• Develop and manage the system architecture and design development pipeline to validate new ideas and technologies.

• Heavily contribute to the intellectual property portfolio.

System Integration and Testing:

• Guide system integration test teams on the verification and validation cycles of the IoT interoperability system.

• Design software development tools that best mimic healthcare institutions' environments using interoperability solutions for innovation and testing purposes.

• Ensure system architectures and interfaces meet technology vision and business needs.

Leadership and Collaboration:

• Provide technical leadership and guidance to multi-functional teams, including developers, engineers, and quality assurance professionals.

• Collaborate with marketing teams to gather system inputs that are actionable by development teams.

• Communicate effectively with both technical and non-technical partners, ensuring a clear understanding of architectural decisions and trade-offs.

Technical and Interpersonal Competencies:

Technical Leadership:

• Experience in architecture design and implementation for complex, scalable enterprise solutions.

• Deep understanding of interface protocols and scalable architecture patterns.

• Familiarity with the software product lifecycle, including documentation, concept, delivery, maintenance, and testing.

• Strong verbal and written communication and collaboration skills.

Technical Expertise:

• Proficiency in system design and software architecture, architectural patterns, and domain driven design.

• Proficiency in high-level programming languages and concepts such as object-oriented design and design patterns.

• Experience with RTOS embedded devices integrated into a broader information system.

• Understanding of requirements management, hazard analysis, and risk controls.

• Knowledge of applicable medical device standards such as IEC 60601, IEC 62304, ISO 13485, IHE, FDA, and HIPAA.

• Background in cybersecurity standards and practices such as MITRE, OWASP, NIST, and FIPS.

• Proficiency in statistical methods, algorithms, and any mathematical usage related to data science.

• Participation in Agile or Scrum methodologies.

Education and Experience Required:

• Bachelor's or Master's degree in Science or Engineering such as Computer Science, Physics, Electrical Engineering, Biomedical Engineering, Cognitive Science, or Mathematics.