Systems Engineer-Medical Device R&D

Key Responsibilities

• Drive system engineering activities across the complete V-Model, from concept development and requirements definition to integration, verification, and validation.
• Define system requirements, architecture, interfaces, and functional and technical designs in alignment with product requirements, risk analysis, and applicable industry standards.
• Perform system design analysis, component selection, and control method definition.
• Coordinate system integration, product builds, and resolution of technical integration issues.
• Support verification and validation planning, system testing, and safety agency interactions.
• Conduct system and subsystem design reviews to ensure products meet customer requirements and are manufacturable, serviceable, reliable, and safe.
• Apply model-based systems engineering approaches and appropriate engineering tools.
• Ensure compliance with medical device regulations, quality requirements, and medical device design principles.
• Collaborate with global engineering teams and contribute to training and coaching system engineers and system architects.
• Support activities across the product lifecycle, including development, manufacturing, deployment, maintenance, and phase-out.

Required Skills & Qualifications

• 5-10 years of experience in systems engineering, preferably in medical device development.
• Strong understanding of the V-Model and systems engineering processes.
• Experience in system requirements, architecture, interface definition, system design, and product integration.
• Knowledge of verification and validation, risk analysis, design reviews, and engineering documentation.
• Familiarity with medical device quality standards and regulatory requirements, including ISO 13485.
• Experience with model-based systems engineering and systems engineering tools.
• Strong cross-functional collaboration, technical communication, and problem-solving skills.