Senior Systems Engineer
Werfen
Summary
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.
Job description
Key Accountabilities
- 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.
Skills & Capabilities
- 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.
Requirements
- 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
- Knowledge of medical device standards and regulations, including ISO 14971, IEC 62304, IEC 62366, and FDA GMP/QSR
- 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 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
- 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
- Proficiency in English language required
Benefits
- Medical, Dental & Vision
- 401(k) Matching
- Paid Vacation
- Sick Leave
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.