Senior Systems Engineer

Introduction

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 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.

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.

Key Accountabilities

Essential Functions:

• 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:

The ideal candidate for this position will exhibit the following skills and capabilities:

• Knowledge of medical device standards and regulations, including ISO 14971, IEC 62304, IEC 62366, and FDA GMP/QSR, and…