Staff Engineer, Verification Automation
Werfen
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.
Job description
Key Accountabilities
- 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.
Minimum 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.
Requirements
- 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.
- 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.
- Strong communication and presentation skills required.
- Strong planning and organizational skills required.
- Experience leading system verification activities.
- Experience testing analog and digital/real-time embedded devices desired.
- Familiarity with reliability testing is desired.
- Broad technical understanding of multiple disciplines from electrical, mechanical, software is desired.
- Good team player and leader.
Benefits
- Medical, Dental & Vision
- 401(k) Matching
- Paid Vacation
- Sick Leave
- Bonus Eligible
Company overview
Werfen is a global leader in specialized diagnostics, founded in 1966 in Barcelona, Spain as a family-owned innovative company. The organization has established itself as a worldwide authority in five key clinical areas: Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant diagnostics. With headquarters in Barcelona and technology centers strategically located in the United States and Europe, Werfen operates directly in 30 countries and serves more than 100 territories through distributors. The company achieved remarkable financial performance with worldwide sales exceeding €2.2 billion in 2024, supported by a workforce of over 7,000 employees globally. Werfen's comprehensive portfolio includes advanced diagnostic systems, reagents, laboratory automation solutions, and point-of-care testing platforms that enable healthcare providers to deliver precise and timely patient care. Their innovative technologies span from blood gas analyzers with hemolysis detection capabilities to automated immunoassay systems and specialized diagnostic assays. As a vertically integrated diagnostics company, Werfen maintains complete control over research, development, manufacturing, and distribution, ensuring quality and reliability across their product lines while continuously advancing diagnostic science to address critical healthcare challenges worldwide.