Systems Engineer III

Position Title: Systems Engineer III
Work Location: Bellevue WA (Hybrid)

Job Summary:

STAFFXPERT is seeking an experienced Systems Engineer III to support the development of connected medical device systems within the Cardiology and Ambulatory Cardiac Monitoring domain. The ideal candidate will have strong experience in end-to-end system integration involving hardware software cloud mobile applications and data pipelines with a focus on verification & validation in regulated healthcare environments.

Key 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 The Organization Product Development process.

Qualification & Experience:
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.
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.

Required Background
Bachelors or Masters 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