Jobs at Werfen

Senior Staff Software Engineer leading technical strategy and architecture for embedded, connected medical-device software. Will resolve cross-functional technical issues spanning software, hardware, systems, and quality; identify architectural improvements and technical debt; mentor engineers; and drive design reviews and coding standards.…See more Requires 12+ years of professional software development with medical-device or regulated systems experience, proficiency in C/C++, embedded Linux/RTOS, and network-connected device design.

Associate Systems Engineer supporting the development and enhancement of in-vitro diagnostic (IVD) instruments within a regulated medical device environment. The role involves system integration testing, verification and validation (V&V) activities, troubleshooting, failure investigations, and risk assessments across multiple R&D projects.…See more Responsibilities include executing statistical analyses, performing root cause analysis, contributing to design control documentation and regulatory submissions, and collaborating with cross-functional teams (software, hardware, assay development, quality, manufacturing). Requires a Bachelor's degree in Systems Engineering, Bioengineering, Mechanical Engineering, Electrical Engineering, or related field with 0–3 years of relevant experience; Master's preferred.

The Systems Engineer applies systems engineering discipline to define, develop, integrate, and test complex in vitro diagnostic medical devices. Responsibilities include capturing user requirements, authoring system and subsystem requirements documentation, conducting hazard and risk analysis, managing configuration and change control, driving system integration and root-cause analysis, and coordinating with development, testing, clinical, and cross-functional teams.…See more The role requires a BS in engineering, 10+ years of industry experience, proven medical device development background, and proficiency in systems engineering methodologies including requirements decomposition, architecture, design reviews, and risk management.

Senior Staff Software Engineer leading technical strategy and problem-solving across software, systems, electrical, and quality functions for regulated medical-device products. Responsible for architecting embedded, connected, network-enabled systems; resolving cross-functional technical challenges; mentoring engineers; and ensuring compliance with FDA, IVDR, and international regulatory standards.…See more Requires 12+ years of professional software development experience with embedded or software-intensive products, deep proficiency in C/C++, embedded Linux or RTOS, and proven expertise in networked device design, secure communications, and design-control processes for medical devices or safety-critical systems.

Staff Software Engineer responsible for leading macro-level technical design, architectural implementation, and development of critical embedded software subsystems in C++ and Qt. The role owns end-to-end software lifecycle deliverables, conducts architecture and design reviews, ensures FDA/IVDR regulatory compliance, and mentors junior engineers.…See more Requires 10+ years of professional experience with complex embedded systems, expert-level C/C++ proficiency, and mastery of object-oriented design and UML modeling.

The Systems Engineer applies interdisciplinary expertise to define, develop, integrate, and test complex In Vitro Diagnostic systems for medical device applications. Responsibilities include documenting user and system requirements, decomposing system architecture into subsystems with defined interfaces, conducting hazard and risk analysis, managing configuration and change control, driving system integration and root-cause analysis, and supporting clinical validation.…See more The role requires 10+ years of industry experience with demonstrated mastery of the full product development lifecycle in medical device or regulated environments, including risk management, design reviews, and cross-functional collaboration with development, testing, and clinical teams.