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 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.
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.
