Principal Systems Engineer - Medical Devices (End-to-End Systems)

What You'll Be Doing

• Systems Engineering Leadership (End-to-End):
• Lead the definition of system architecture, requirements, and specifications for end-to-end medical device systems, ensuring seamless integration and interoperability between wearable devices, gateways, cloud infrastructure, mobile applications, and dashboards.
• Develop comprehensive system models, risk analyses, and mitigation strategies, addressing the unique challenges of each component in the end-to-end system.
• Guide cross-functional teams (hardware, software, firmware, cloud, mobile, data science, clinical, quality) through the systems engineering process, ensuring alignment with cybersecurity, regulatory, and performance requirements across the entire system.


• Technical Expertise (Full Stack):
• Provide expert guidance on technical challenges and design trade-offs across the end-to-end system, encompassing hardware (wearables, sensors, gateways), software (mobile apps, dashboards, algorithms), and cloud infrastructure.
• Evaluate and select appropriate technologies and components for each element of the end-to-end system, considering factors like power consumption, connectivity, security, and data throughput.
• Conduct in-depth analysis of system performance, reliability, and data integrity across the entire data pipeline, from sensor data collection to cloud storage and processing.


• Cybersecurity, Requirement Management, and V&V:
• Implement end-to-end cybersecurity controls and measures to protect patient data and ensure the confidentiality, integrity, and availability of medical device systems.
• Define, document, and manage system requirements across all components of the end-to-end system, ensuring traceability and alignment with regulatory standards.
• Oversee comprehensive test plans and protocols to verify and validate system performance, safety, and cybersecurity across the entire end-to-end ecosystem.


• Data Engineering and Algorithms:
• Collaborate with data engineers and scientists to design and implement robust data pipelines for collecting, processing, and analyzing data from wearable devices and sensors.

What You Bring

• Education: 
• Bachelor's degree (Master's preferred) in Systems Engineering, Biomedical Engineering, Computer Engineering, Electrical Engineering, or a related field.


• Experience:
• 10+ years of experience in systems engineering, with a significant focus on medical devices or other complex, end-to-end systems involving hardware and software integration.
• Demonstrated success in leading the development of end-to-end systems, ideally in the medical device or healthcare industry.
• Proven expertise in systems modeling, requirements management, risk analysis, cybersecurity risk assessments, and verification/validation across hardware and software components.
• Strong understanding of medical device regulations, quality systems, cybersecurity frameworks, and data privacy regulations (e.g., HIPAA).


• Skills:
• Broad technical knowledge encompassing hardware (sensors, embedded systems), software (mobile apps, cloud applications, algorithms), and data engineering.
• Understanding of human physiology and state of the art medical device technology. Deep understanding of at least 1 common vital sign is preferred.
• Demonstrated ability to work across disciplines to build consensus and drive complex systems to completion.
• Experience converting complex technical, business and regulatory requirements or challenges into clear and actionable strategies.
• Thorough understanding of, and experience with, medical device risk management and regulations.
• Experience in requirements definition and flow down, management, validation, and verification practices.
• Excellent communication, self-management, planning and organization, attention to detail, and ability to motivate and engage team members.
• Able to work well within a high growth, collaborative team environment and adapt quickly to change.