About this role
Ihre Aufgaben The position leads the Systems Engineering and Quality Engineering teams and is<br>accountable for their people, objectives, resources, capabilities, and results. The role<br>ensures that customer, user, regulatory, and business needs are translated into robust<br>system architectures, complete and traceable requirements, effective risk management,<br>and appropriate verification and validation evidence. It owns the integration of design<br>control and quality engineering throughout the product lifecycle, promotes a risk-based<br>quality culture, and collaborates closely with R&D, Regulatory Affairs, Quality Assurance,<br>Software, Hardware, Mechanical, Usability, Production, Service, and external partners.<br>Primary Responsibilities:<br>a) People Leadership and Team Development<br>• Provide functional and people leadership for the Systems Engineering and Quality<br>Engineering teams.<br>• Set team objectives, priorities, roles, capacity plans, and development plans aligned<br>with product and company strategy.<br>• Coach employees, provide regular feedback, develop performance and capabilities,<br>and support recruiting and onboarding.<br>• Build a culture of collaboration, accountability, continuous improvement, and early<br>escalation.<br>• Plan and manage internal and external resources, budgets, and deliverables.<br>b) Systems Engineering<br>• Own Systems Engineering processes and deliverables from stakeholder needs<br>through system verification and validation.<br>• Ensure coherent system architecture, clearly defined interfaces, and complete<br>bidirectional traceability.<br>• Lead requirements management, system integration, technical reviews, trade-off<br>decisions, and technical problem solving.<br>• Align system requirements with Software, Hardware, Mechanical, Usability,<br>Production, and Service teams.<br>c) Quality Engineering and Design Assurance<br>• Own independent, risk-based Quality Engineering support for product development<br>and the effectiveness of design-control activities<br>• Ensure the quality and completeness of design inputs, design outputs, reviews, risk<br>management, verification, validation, and design transfer.<br>• Monitor and analyze quality metrics, nonconformities, CAPA, change controls, and<br>product risks; drive sustainable improvements.<br>• Support audits, inspections, regulatory submissions, and the creation of objective<br>development evidence.<br>d) Development Governance and Delivery<br>• Represent Systems Engineering and Quality Engineering in project, portfolio, and<br>management governance.<br>• Define and continuously improve shared processes, methods, templates, tools, and<br>performance indicators.<br>• Ensure risk-based planning of reviews, integration, verification, validation, and<br>design transfer.<br>• Provide transparent reporting on progress, quality, capacity, risks, and decisions<br>required.<br>• Resolve cross-functional conflicts and escalate critical product, quality, and resource<br>risks in a timely manner. Ihr Profil • At least 10 years of experience in regulated medical-device development, including<br>several years of people leadership or functional leadership<br>• Degree in electrical engineering, medical engineering, mechanical engineering,<br>systems engineering, or a comparable technical discipline; advanced qualification in<br>quality management or leadership is an advantage.<br>• Demonstrated experience in systems engineering, requirements engineering,<br>system architecture, integration, verification, and validation.<br>• Strong experience in quality engineering, design control, risk management, CAPA,<br>change control, and design transfer.<br>• Sound knowledge of applicable regulations and standards, particularly EU MDR,<br>FDA Quality System Regulation, ISO 13485, ISO 14971, and IEC 60601.<br>• Experience with ALM/PLM and quality-management tools such as Codebeamer,<br>Polarion, or DOORS.<br>• Experience leading cross-functional teams, external partners, budgets, and multiple<br>concurrent development projects.<br>• Strong analytical and problem-solving skills<br>• Ability to interpret complex standards and regulations<br>• Strong communication and stakeholder management<br>• Ability to challenge design decisions constructively<br>• Cross-functional collaboration mindset<br>• Structured and detail-oriented working style Warum wir? <ul style="border:0px solid;color:rgb(31,31,31);font-size:14px;font-style:normal;font-weight:400;text-transform:none;font-family:Inter, '-apple-system', BlinkMacSystemFont, 'Segoe UI', Roboto, 'Helvetica Neue', 'Open Sans', 'system-ui', '-apple-system', 'Segoe UI', Roboto, Ubuntu, Cantarell, 'Noto Sans', sans-serif, 'Apple Color Emoji', 'Segoe UI Emoji';background-color:rgb(255,255,255);"><li style="border:0px solid;margin:0px;">Personal induction plan and comprehensive onboarding</li><li style="border:0px solid;margin:0px;">Flexible working hours</li><li style="border:0px solid;margin:0px;">30 days of holiday</li><li style="border:0px solid;margin:0px;">interesting tasks in a dynamic, international environment</li><li style="border:0px solid;margin:0px;">Continuous training and development</li><li style="border:0px solid;margin:0px;">Flat hierarchies</li><li style="border:0px solid;margin:0px;">Attractive canteen</li><li style="border:0px solid;margin:0px;">Free coffee, tea and water</li><li style="border:0px solid;margin:0px;">Employee events</li><li style="border:0px solid;margin:0px;">Charging stations for electric cars</li><li style="border:0px solid;margin:0px;">Accident insurance</li><li style="border:0px solid;margin:0px;">Employer contribution to VWL</li><li style="border:0px solid;margin:0px;">Employee fund with various allowances and subsidies</li><li style="border:0px solid;margin:0px;">Free language courses</li></ul>