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

Ihre Aufgaben

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.

1. People Leadership and Team Development

• Provide functional and people leadership for the Systems Engineering and Quality

• Set team objectives, priorities, roles, capacity plans, and development plans aligned

• Coach employees, provide regular feedback, develop performance and capabilities,

• Build a culture of collaboration, accountability, continuous improvement, and early

• Plan and manage internal and external resources, budgets, and deliverables.

1. Systems Engineering

• Own Systems Engineering processes and deliverables from stakeholder needs

• Ensure coherent system architecture, clearly defined interfaces, and complete

• Lead requirements management, system integration, technical reviews, trade-off

• Align system requirements with Software, Hardware, Mechanical, Usability,

1. Quality Engineering and Design Assurance

• Own independent, risk-based Quality Engineering support for product development

• Ensure the quality and completeness of design inputs, design outputs, reviews, risk

• Monitor and analyze quality metrics, nonconformities, CAPA, change controls, and

• Support audits, inspections, regulatory submissions, and the creation of objective

1. Development Governance and Delivery

• Represent Systems Engineering and Quality Engineering in project, portfolio, and

• Define and continuously improve shared processes, methods, templates, tools, and

• Ensure risk-based planning of reviews, integration, verification, validation, and

• Provide transparent reporting on progress, quality, capacity, risks, and decisions

• Resolve cross-functional conflicts and escalate critical product, quality, and resource

risks in a timely manner.

• At least 10 years of experience in regulated medical-device development, including

• Degree in electrical engineering, medical engineering, mechanical engineering,

• Demonstrated experience in systems engineering, requirements engineering,

• Strong experience in quality engineering, design control, risk management, CAPA,

• Sound knowledge of applicable regulations and standards, particularly EU MDR,

• Experience with ALM/PLM and quality-management tools such as Codebeamer,

• Experience leading cross-functional teams, external partners, budgets, and multiple

• 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

• 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

Über uns

Dornier MedTech ist ein Unternehmen für Medizinprodukte mit Hauptsitz in der Nähe von München, Deutschland, und eine hundertprozentige Tochtergesellschaft von Advanced MedTech. Als Pionier auf dem Gebiet der Urologie ist Dornier einer der vertrauenswürdigsten Namen in der Branche.