Teamleader Systems and Quality Engineering (m/w/f)

Dornier MedTech; Weichselbaum; On-site; EUR 90,000 - 130,000; Full time

Benefits offered by this job

Flexible Arbeitszeiten

30 Urlaubstage pro Jahr

Weiterbildung und Schulungen

Dynamisches internationales Umfeld

Flache Hierarchien

Kostenlose Getränke/Kaffee

Job summary

Dornier MedTech sucht eine erfahrene Führungskraft im Bereich Systems Engineering und Quality Engineering für die Steuerung von Teams und Produktlebenszyklen in der regulierten Medizintechnik.

Sie verantworten die Integration von Design Control, Risikomanagement und Verifikation/Validierung, arbeiten eng mit Regulatory Affairs, QA, R&D und externen Partnern zusammen und treiben eine risikoorientierte Qualitätskultur voran.

Qualifications

• Mindestens 10 Jahre Erfahrung in regulierter Medizingeräteentwicklung.
• Führungserfahrung oder Funktionsführung erforderlich.
• Kenntnisse in Systemen, Anforderungen, Architektur, Integration, Verifikation und Validierung.

Responsibilities

• Führung der Systems Engineering und Quality Engineering Teams und Ressourcenplanung.
• Steuerung von Systemarchitektur, Anforderungen, Verifikation und Validierung.
• Risikomanagement, CAPA, Änderungsverfahren und Design-Transfer sicherstellen.
• Zusammenarbeit mit R&D, Regulatory Affairs, QA, Software, Hardware, Produktion und externen Partnern.

Skills

People leadership

Systems engineering

Quality engineering

Regulatory knowledge

Risk management

Cross-functional collaboration

Stakeholder management

Analytical thinking

Problem-solving

Communication

Education

Electrical/Medical/Mechanical Systems Engineering degree

Tools

Codebeamer

Polarion

DOORS

Job description

Ihre Aufgaben

The position leads the Systems Engineering and Quality Engineering teams and is accountable for their people, objectives, resources, capabilities, and results. The role ensures that customer, user, regulatory, and business needs are translated into robust system architectures, complete and traceable requirements, effective risk management, and appropriate verification and validation evidence. It owns the integration of design control and quality engineering throughout the product lifecycle, promotes a risk-based quality culture, and collaborates closely with R&D, Regulatory Affairs, Quality Assurance, Software, Hardware, Mechanical, Usability, Production, Service, and external partners. Primary Responsibilities: a) People Leadership and Team Development Provide functional and people leadership for the Systems Engineering and Quality Engineering teams. Set team objectives, priorities, roles, capacity plans, and development plans aligned with product and company strategy. Coach employees, provide regular feedback, develop performance and capabilities, and support recruiting and onboarding. Build a culture of collaboration, accountability, continuous improvement, and early escalation. Plan and manage internal and external resources, budgets, and deliverables. b) Systems Engineering Own Systems Engineering processes and deliverables from stakeholder needs through system verification and validation. Ensure coherent system architecture, clearly defined interfaces, and complete bidirectional traceability. Lead requirements management, system integration, technical reviews, trade-off decisions, and technical problem solving. Align system requirements with Software, Hardware, Mechanical, Usability, Production, and Service teams. c) Quality Engineering and Design Assurance Own independent, risk-based Quality Engineering support for product development and the effectiveness of design-control activities Ensure the quality and completeness of design inputs, design outputs, reviews, risk management, verification, validation, and design transfer. Monitor and analyze quality metrics, nonconformities, CAPA, change controls, and product risks; drive sustainable improvements. Support audits, inspections, regulatory submissions, and the creation of objective dvelopment evidence. d) Development Governance and Delivery Represent Systems Engineering and Quality Engineering in project, portfolio, and management governance. Define and continuously improve shared processes, methods, templates, tools, and performance indicators. Ensure risk-based planning of reviews, integration, verification, validation, and design transfer. Provide transparent reporting on progress, quality, capacity, risks, and decisions required. Resolve cross-functional conflicts and elevate critical product, quality, and resource risks in a timely manner.

Ihr Profil

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 engineering, or a comparable technical discipline; advanced qualification in quality management or leadership is an advantage. Demonstrated experience in systems engineering, requirements engineering, system architecture, integration, verification, and validation. Strong experience in quality engineering, design control, risk management, CAPA, change control, and design transfer. Sound knowledge of applicable regulations and standards, particularly EU MDR, FDA Quality System Regulation, ISO 13485, ISO 14971, and IEC 60601. Experience with ALM/PLM and quality-management tools such as Codebeamer, Polarion, or DOORS. Experience leading cross-functional teams, external partners, budgets, and multiple concurrent development projects. Strong analytical and problem-solving skills Ability to interpret complex standards and regulations Strong communication and stakeholder management Ability to challenge design decisions constructively Cross-functional collaboration mindset Structured and detail-oriented working style

Warum wir?

• Personal induction plan and comprehensive onboarding
• Flexible working hours
• 30 days of holiday
• interesting tasks in a dynamic, international environment
• Continuous training and development
• Flat hierarchies
• Attractive canteen
• Free coffee, tea and water
• Employee events
• Charging stations for electric cars
• Accident insurance
• Employer contribution to VWL
• Employee fund with various allowances and subsidies
• Free language courses