{"id":82079,"title":"Teamleader Systems and Quality Engineering (m/w/f)","company":"Dornier MedTech Systems GmbH","city":null,"region":null,"location":"DMT-Germany - Wessling","work_model":"unknown","employment_type":"full_time","employment":["full_time"],"roles":["leadership"],"visa":"not_mentioned","relocation":"not_mentioned","posted_at":"2026-09-29T14:35:05+00:00","tools":[],"seniority":"senior","years_experience_min":10,"german_requirement":"not_mentioned","german_level":"unspecified","english_requirement":"required","english_level":"unspecified","team_language":"unknown","confidence":0.4,"method":"rules","language_badge":"Not stated","language_evidence":null,"requirements_snippet":"At least 10 years of experience in regulated medical-device development, including several years of people leadership or functional leadership Degree in electrical engineering, medical engineering, mechanical engineering, systems …","url":"https://dornier-medtech.jobs.personio.de/job/2819281","source":"personio","agency":null,"description_text":"Ihre Aufgaben\nThe position leads the Systems Engineering and Quality Engineering teams and is\naccountable for their people, objectives, resources, capabilities, and results. The role\nensures that customer, user, regulatory, and business needs are translated into robust\nsystem architectures, complete and traceable requirements, effective risk management,\nand appropriate verification and validation evidence. It owns the integration of design\ncontrol and quality engineering throughout the product lifecycle, promotes a risk-based\nquality culture, and collaborates closely with R&D, Regulatory Affairs, Quality Assurance,\nSoftware, Hardware, Mechanical, Usability, Production, Service, and external partners.\nPrimary Responsibilities:\na) People Leadership and Team Development\n• Provide functional and people leadership for the Systems Engineering and Quality\nEngineering teams.\n• Set team objectives, priorities, roles, capacity plans, and development plans aligned\nwith product and company strategy.\n• Coach employees, provide regular feedback, develop performance and capabilities,\nand support recruiting and onboarding.\n• Build a culture of collaboration, accountability, continuous improvement, and early\nescalation.\n• Plan and manage internal and external resources, budgets, and deliverables.\nb) Systems Engineering\n• Own Systems Engineering processes and deliverables from stakeholder needs\nthrough system verification and validation.\n• Ensure coherent system architecture, clearly defined interfaces, and complete\nbidirectional traceability.\n• Lead requirements management, system integration, technical reviews, trade-off\ndecisions, and technical problem solving.\n• Align system requirements with Software, Hardware, Mechanical, Usability,\nProduction, and Service teams.\nc) Quality Engineering and Design Assurance\n• Own independent, risk-based Quality Engineering support for product development\nand the effectiveness of design-control activities\n• Ensure the quality and completeness of design inputs, design outputs, reviews, risk\nmanagement, verification, validation, and design transfer.\n• Monitor and analyze quality metrics, nonconformities, CAPA, change controls, and\nproduct risks; drive sustainable improvements.\n• Support audits, inspections, regulatory submissions, and the creation of objective\ndevelopment evidence.\nd) Development Governance and Delivery\n• Represent Systems Engineering and Quality Engineering in project, portfolio, and\nmanagement governance.\n• Define and continuously improve shared processes, methods, templates, tools, and\nperformance indicators.\n• Ensure risk-based planning of reviews, integration, verification, validation, and\ndesign transfer.\n• Provide transparent reporting on progress, quality, capacity, risks, and decisions\nrequired.\n• Resolve cross-functional conflicts and escalate critical product, quality, and resource\nrisks in a timely manner.\n\nIhr Profil\n• At least 10 years of experience in regulated medical-device development, including\nseveral years of people leadership or functional leadership\n• Degree in electrical engineering, medical engineering, mechanical engineering,\nsystems engineering, or a comparable technical discipline; advanced qualification in\nquality management or leadership is an advantage.\n• Demonstrated experience in systems engineering, requirements engineering,\nsystem architecture, integration, verification, and validation.\n• Strong experience in quality engineering, design control, risk management, CAPA,\nchange control, and design transfer.\n• Sound knowledge of applicable regulations and standards, particularly EU MDR,\nFDA Quality System Regulation, ISO 13485, ISO 14971, and IEC 60601.\n• Experience with ALM/PLM and quality-management tools such as Codebeamer,\nPolarion, or DOORS.\n• Experience leading cross-functional teams, external partners, budgets, and multiple\nconcurrent development projects.\n• Strong analytical and problem-solving skills\n• Ability to interpret complex standards and regulations\n• Strong communication and stakeholder management\n• Ability to challenge design decisions constructively\n• Cross-functional collaboration mindset\n• Structured and detail-oriented working style\n\nWarum wir?\n• Personal induction plan and comprehensive onboarding\n• Flexible working hours\n• 30 days of holiday\n• interesting tasks in a dynamic, international environment\n• Continuous training and development\n• Flat hierarchies\n• Attractive canteen\n• Free coffee, tea and water\n• Employee events\n• Charging stations for electric cars\n• Accident insurance\n• Employer contribution to VWL\n• Employee fund with various allowances and subsidies\n• Free language courses","responsibilities_text":"The position leads the Systems Engineering and Quality Engineering teams and is\naccountable for their people, objectives, resources, capabilities, and results. The role\nensures that customer, user, regulatory, and business needs are translated into robust\nsystem architectures, complete and traceable requirements, effective risk management,\nand appropriate verification and validation evidence. It owns the integration of design\ncontrol and quality engineering throughout the product lifecycle, promotes a risk-based\nquality culture, and collaborates closely with R&D, Regulatory Affairs, Quality Assurance,\nSoftware, Hardware, Mechanical, Usability, Production, Service, and external partners.\nPrimary Responsibilities:\na) People Leadership and Team Development\n• Provide functional and people leadership for the Systems Engineering and Quality\nEngineering teams.\n• Set team objectives, priorities, roles, capacity plans, and development plans aligned\nwith product and company strategy.\n• Coach employees, provide regular feedback, develop performance and capabilities,\nand support recruiting and onboarding.\n• Build a culture of collaboration, accountability, continuous improvement, and early\nescalation.\n• Plan and manage internal and external resources, budgets, and deliverables.\nb) Systems Engineering\n• Own Systems Engineering processes and deliverables from stakeholder needs\nthrough system verification and validation.\n• Ensure coherent system architecture, clearly defined interfaces, and complete\nbidirectional traceability.\n• Lead requirements management, system integration, technical reviews, trade-off\ndecisions, and technical problem solving.\n• Align system requirements with Software, Hardware, Mechanical, Usability,\nProduction, and Service teams.\nc) Quality Engineering and Design Assurance\n• Own independent, risk-based Quality Engineering support for product development\nand the effectiveness of design-control activities\n• Ensure the quality and completeness of design inputs, design outputs, reviews, risk\nmanagement, verification, validation, and design transfer.\n• Monitor and analyze quality metrics, nonconformities, CAPA, change controls, and\nproduct risks; drive sustainable improvements.\n• Support audits, inspections, regulatory submissions, and the creation of objective\ndevelopment evidence.\nd) Development Governance and Delivery\n• Represent Systems Engineering and Quality Engineering in project, portfolio, and\nmanagement governance.\n• Define and continuously improve shared processes, methods, templates, tools, and\nperformance indicators.\n• Ensure risk-based planning of reviews, integration, verification, validation, and\ndesign transfer.\n• Provide transparent reporting on progress, quality, capacity, risks, and decisions\nrequired.\n• Resolve cross-functional conflicts and escalate critical product, quality, and resource\nrisks in a timely manner.","requirements_text":"• At least 10 years of experience in regulated medical-device development, including\nseveral years of people leadership or functional leadership\n• Degree in electrical engineering, medical engineering, mechanical engineering,\nsystems engineering, or a comparable technical discipline; advanced qualification in\nquality management or leadership is an advantage.\n• Demonstrated experience in systems engineering, requirements engineering,\nsystem architecture, integration, verification, and validation.\n• Strong experience in quality engineering, design control, risk management, CAPA,\nchange control, and design transfer.\n• Sound knowledge of applicable regulations and standards, particularly EU MDR,\nFDA Quality System Regulation, ISO 13485, ISO 14971, and IEC 60601.\n• Experience with ALM/PLM and quality-management tools such as Codebeamer,\nPolarion, or DOORS.\n• Experience leading cross-functional teams, external partners, budgets, and multiple\nconcurrent development projects.\n• Strong analytical and problem-solving skills\n• Ability to interpret complex standards and regulations\n• Strong communication and stakeholder management\n• Ability to challenge design decisions constructively\n• Cross-functional collaboration mindset\n• Structured and detail-oriented working style\nWarum wir?\n• Personal induction plan and comprehensive onboarding\n• Flexible working hours\n• 30 days of holiday\n• interesting tasks in a dynamic, international environment\n• Continuous training and development\n• Flat hierarchies\n• Attractive canteen\n• Free coffee, tea and water\n• Employee events\n• Charging stations for electric cars\n• Accident insurance\n• Employer contribution to VWL\n• Employee fund with various allowances and subsidies\n• Free language courses","status":"open","duplicate_of":null,"first_seen":"2026-11-04T00:19:43.226789+00:00","responsibilities_summary":null,"requirements_summary":null,"all_tools":[],"posting_language":"en","evidence":[],"years_experience_max":null,"mobility_evidence":[],"model_version":"rules-8","english_badge":"English required","company_id":2549}