Senior Verification and Validation Engineer

A BIT ABOUT SIBEL HEALTH:

With headquarters based in Chicago, IL and an international office in Seoul, South Korea, Sibel Health is an award-winning digital health startup with a mission to deliver Better Health Data for All®. We were founded out of a Northwestern University Biotechnology lab, with a specific focus on our most vulnerable patients - pregnant persons and babies - where we believe wireless monitoring has the potential to do the most good worldwide.

We are seeking mission-driven individuals with a strong sense of purpose who believe that technology can improve the lives of our most vulnerable patients.

THE OPPORTUNITY:

We are seeking a Senior Verification & Validation Engineer to drive product verification and validation planning and execution for products in our Discovery and Clinical portfolio, including wearable sensors and medical monitoring system solutions. You will be responsible for reviewing requirements to ensure clear and testable requirements, defining V&V test strategy, creating and managing verification test plans, protocols, and reports, and providing technical leadership to a distributed team of in-house, contract, and offshore test engineers.

You will be a critical member of a cross-functional team in pursuit of delivering innovative and quality products that adhere to our technical designs and meet the needs of our customers. We value candidates who have a strong work ethic, are detail-oriented, and are passionate about producing objective, reproducible evidence that our products meet their requirements and are safe for their intended use.

This role offers a clear opportunity to grow into technical leadership of the V&V function. This is a great opportunity to join a diverse, innovative, and passionate team that shares a common vision to provide Better Health Data for All®.

WHAT YOU WILL BE WORKING ON:

• Plan and manage the verification activities for multiple projects, coordinating with project management on verification timelines, deliverables, and readiness.
• Review and examine requirements, interface specifications, UI/, and technical design documents, ensuring requirements are clear, unambiguous, and objectively verifiable.
• Translate requirements and design documents into verification protocols that verify the requirement, taking into account clinical use cases.
• Define and implement test strategies and methodologies for multiple projects, including system-level and system-of-systems (end-to-end) verification across integration and verification milestones.
• Verify implementation and effectiveness of risk controls in accordance with ISO 14971 and the product risk management file.
• Own requirements-to-verification traceability in Jama Connect, identifying and closing gaps in coverage.
• Perform manual and automated testing and analysis to identify and document any anomalies.
• Lead anomaly investigation and triage, and define regression scope based on change impact analysis.
• Own the verification test environment, ensuring configuration is controlled, documented, and reproducible.
• Maintain accurate and complete documentation of all verification activities, including verification plans, verification reports, and anomalies reports.
• Support validation activities in accordance with the V&V Plan, working closely with Design Engineering (usability/human factors) and Product Management.
• Proactively collaborate with other groups including Systems Engineering, Design Engineering, Product Management, Quality/Regulatory, and the Engineering teams (SW, HW, FW, Algorithm).
• Work within an Agile team environment, supporting in-sprint verification activities and planning.

TECHNICAL LEADERSHIP:

• Review test cases, protocols, and executed results authored by other team members…