Description

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
• 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

Key Skills

Education

Bachelor's or Master's degrees