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 development 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 escalate 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
