Principal Systems Engineer

Stefanini Group•Bellevue, WA

11h•Hybrid

About The Position

Stefanini Group is hiring a Principal Systems Engineer in Bellevue, WA. This is a hybrid role that allows a flexible schedule for remote and onsite work. The Principal Systems Engineer will have a broad technical background spanning hardware, software, mobile, and cloud technologies with a deep understanding of medical device regulations and best practices. The role involves driving the development and integration of complex, end-to-end medical device systems, including wearable devices with sensors, mobile applications, software algorithms, cloud software applications, user portals and gateways, and data pipelines. Systems engineering principles will be applied throughout the entire product lifecycle, with a focus on verification and validation.

Requirements

Demonstrated success in leading the development of end-to-end systems, ideally in the medical device or healthcare industry.
Proven expertise in systems modelling, requirements management, risk analysis, verification, and validation.
Strong understanding of medical device regulations, quality systems, and data privacy regulations.
Broad technical knowledge encompasses 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.
Critical thinking and problem-solving skills.
An autonomous self-starter personality with a culture of collaboration.
Detail oriented with strong organization and time management skills and the ability to multi-task across a diverse scope of responsibilities, projects, and people.
Effective verbal and written communication skills and the ability to facilitate and work effectively in diverse, multi-functional teams.
Bachelor's or Master's degrees 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.
Debugging skills – ability to trace and resolve hardware and software issues.

Nice To Haves

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.
Familiarity with design/version control and requirement tool is a plus.

Responsibilities

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 clients Product Development process.