Senior Systems Engineer

The Senior Systems Engineer supports system integration, verification, validation, defect analysis, and remediation activities throughout product development. This role is responsible for translating user needs and system requirements into system-level verification and validation test cases, executing and documenting testing activities, supporting product risk management, and ensuring compliance with applicable regulatory requirements and standards. The engineer collaborates with cross-functional teams to analyze test results, identify issues and risks, support issue resolution, and verify the implementation and effectiveness of risk controls., * Owns system-level defect analysis and remediation during System Integration, Verification, and Validation phases.

• Supports Product Risk Management activities, regulatory and standards compliance, and country approval efforts.
• Conducts risk analyses, including Design Failure Mode and Effects Analysis (DFMEA), and supports the development of risk control measures.
• Translates user needs and system requirements into system-level verification and validation test cases with appropriate traceability.
• Executes and documents system integration, verification, and validation testing involving hardware, software, subsystems, and external interfaces.
• Analyzes test results, identifies issues and risks, and collaborates with cross-functional teams to support timely resolution.
• Participates in system test, technical, and design reviews with a focus on verification coverage, defects, and readiness milestones.
• Supports Product Safety Risk Management activities by verifying implementation and effectiveness of assigned risk controls in a regulation-compliant manner.
• Applies standard test practices, tools, and templates and contributes to continuous improvement of system test processes.
• Conducts cascade analysis and error budget allocation
• Effectively communicates complex technical information to a cross-functional team in the form of documentation, presentations or technical summaries.
• Independently generates predictable schedules for activities related to assigned projects.

• Knowledge of medical device standards and regulations, including ISO 14971, IEC 62304, IEC 62366, and FDA GMP/QSR, and their impact on verification and validation activities.
• Experience executing system-level or integration test activities for complex products.
• Ability to analyze test results and identify issues and risks.
• Ability to support risk management activities, including DFMEA and risk control verification.
• Effective collaboration and communication skills within cross-functional teams.
• Experience with requirements management, digital traceability tools, and test automation preferred.
• Experience working with electromechanical and/or mechatronic systems.
• Knowledge of system integration principles and system-level testing methodologies.
• Understanding of embedded software design, implementation, integration, and test activities.
• Experience with control systems; stepper motor control experience preferred.
• Ability to diagnose and troubleshoot system performance issues using equipment, schematics, and algorithm analysis.
• Programming experience, preferably Python.
• Experience using test and measurement equipment, including oscilloscopes, digital multimeters (DMMs), and logic analyzers., * Bachelor’s degree in Engineering, Science or a related field, * Eight years of product development or relevant experience
• Four to six years of product development or relevant experience for advanced degrees
• For internal candidate promotion: Demonstrated proficiency in meeting all competencies of current level and acceptable performance history may be used in lieu of experience
• In vitro medical device experience highly desired.

Additional Skills/Knowledge:

• Language: Proficiency in English language required

The annual base salary range for this role is currently $110,000 to $140,000. 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.

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., 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.