OverviewPosition Summary:The Staff Systems Verification Engineer partners with cross-functional product development teams to support the integration, verification, and testing of In Vitro Diagnostic (IVD) products. This role provides technical mentorship and guidance to Verification Engineers while ensuring product quality and alignment with market needs. The role includes driving the architectural design, deployment, and practical use of robust test automation frameworks to verify regulated medical device software and hardware. Additional responsibilities include developing and maintaining design verification documentation, participating in product architecture, design, risk, and requirements reviews, and supporting system integration and verification activities throughout the product development lifecycle.
The annual base salary range for this role is currently $150,000 to $185,000. This is a bonus-eligible position. Individual employee compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and particular business needs.
This role is eligible for medical, dental, and vision insurance, 401k plan retirement benefits with an employer match, as well as paid vacation and sick leave.
ResponsibilitiesKey AccountabilitiesEssential Functions:- Drives the architectural design, development, and practical use of robust test automation systems for functional and reliability testing of medical devices.
- Leverages modern AI-driven tools to accelerate and optimize the development of manual and automated verification test cases, protocols, and required engineering artifacts.
- Maintains and versions all automation framework code and scripts utilizing industry-standard version control systems, specifically Git and Bitbucket.
- Utilizes Jama Connect for comprehensive requirement management, test case development, and rigorous tracing of design inputs to design outputs.
- Analyzes requirements and design specifications from a systems perspective, demonstrating a mastery of product use to provide technical leadership in their application.
- Authors and executes key compliance deliverables, including Verification Test Plans, Protocols, and Reports, ensuring strict adherence to medical device quality standards.
- Provides technical leadership and mentorship to project teams and system verification engineers, while driving verification strategies across software, electrical, mechanical, and analytical disciplines.
- Proactively creates work breakdown structures, resource estimates, and progress tracking strategies to ensure project milestones are met on schedule.
- Collaborates cross-functionally with systems, product management, and development teams to drive root-cause analysis, hazard and risk analysis, and comprehensive design reviews.
- Contributes to departmental growth and evolution by participating in candidate interviews for new personnel and actively driving continuous process improvement activities.
Skills & Capabilities:- Strong communication and presentation skills required.
- Strong planning and organizational skills required.
- Experience leading system verification activities.
- Test automation experience required.
- Testing experience in medical device development or other Regulated industry is required.
- Experience in elicitation, writing and traceability of system/subsystem requirements for product development is required.
- Broad technical understanding of multiple disciplines from electrical, mechanical, software is desired.
- Familiarity with reliability testing is desired.
QualificationsMinimum Knowledge & Experience Required for the Position:- BS/BA degree in EE, ME, or related Engineering discipline required.
- 10+ years development and/or testing experience in industry.
- 5+ years testing experience in Medical device development or other Regulated industry required.
- Experience leading testing activities.
- Experience testing analog and digital/real-time embedded devices desired.
- Good communication and presentation skills.
- Good team player and leader.
