Principal Systems Engineer - Medical Devices

This is a hybrid role that allows a flexible schedule for remote and onsite work. Hours will be 8AM to 5PM but could vary

Description:

Client is currently seeking a Principal Systems Engineer to join the R&D team at our Bellevue office. In this role, you will be responsible for driving the development and integration of complex, end-to-end medical device systems that involve wearable devices with sensors, mobile applications, software algorithms, cloud software applications, user portals and gateways, and data pipelines. You will apply systems engineering principles throughout the entire product lifecycle, focusing on verification and validation.

What you'll be doing:

• Evaluate system integration points and lead the team in integration planning and testing between wearable devices, mobile applications, software algorithms, cloud software applications, and user portals.
• Develop and execute comprehensive test plans to verify and validate system performance, safety, and security across the entire end-to-end ecosystem, including test protocol and report write-up.
• Develop comprehensive system models, risk analyses, and mitigation strategies, addressing the unique challenges of each component in the end-to-end system.
• Work with development engineers to analyze system performance, reliability, and data integrity across the entire data pipeline, from wearable device data collection to cloud storage and processing.
• Act as a subject matter expert for project teams in applying systems engineering standards and best practices to the Client Product Development process.

What you'll bring:

• 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, verification, and validation.
• Strong understanding of medical device regulations, quality systems, and data privacy regulations.
• Broad technical knowledge encompassing hardware (such as embedded systems and sensors), software (such as algorithms, cloud and mobile applications), and data engineering.
• Experience in requirements management, validation, and verification practices.
• Experience in developing system design verification and validation plans and functional test procedures.
• Demonstrated ability to work across disciplines to build consensus and drive complex systems to completion.

Required Background

• Bachelor’s or Master’s degree in Electrical Engineering, Biomedical Engineering, Computer Engineering, Systems Engineering, or other technical or science disciplines.
• 5 – 8+ years of experience in systems engineering, with a significant focus on connected medical devices or other complex, end-to-end systems involving hardware and software integration.
• Intermediate knowledge of electro-mechanical hardware qualification and statistics. Knowledge of CAD is a plus.
• Experience in automation and programming/scripting (Python, RESTful API). Familiarity with Azure DevOps (ADO) or similar CI/CD tools is a plus.
• Debugging skills – ability to trace and resolve hardware and software issues.
• Familiarity with design/version control and requirement tool is a plus.