Job description

Werfen Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care. Position 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. Key Accountabilities Essential 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. 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. If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV. Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact NAtalentacquisition@werfen.com for assistance. We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team. www.werfen.com

Requirements

Must-haves

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.
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.

Nice-to-haves

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Application prep

Use the role’s language and application details while tailoring your materials.

Keywords to mirror

Platform: icims
Effort: medium

Benefits

Benefits detected in the listing.

Dental

Vision

401k