Dornier MedTech
Senior Electrical Engineer (m/w/x)
Vollzeitnur vor OrtSenior
Weßling
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DODornier MedTech
Teamleader Systems and Quality Engineering (m/w/x)
VollzeitVor OrtSenior
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Leading systems and quality engineering teams for urology devices. 10+ years in regulated medical device development required. 30 days holiday, flexible working hours.
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Anforderungen
- 10+ years in regulated medical-device development
- Several years of people leadership or functional leadership
- Degree in electrical, medical, mechanical, systems engineering, or comparable technical discipline
- Advanced qualification in quality management or leadership is advantageous
- Demonstrated experience in systems engineering
- Demonstrated experience in requirements engineering
- Demonstrated experience in system architecture
- Demonstrated experience in integration
- Demonstrated experience in verification and validation
- Strong experience in quality engineering
- Strong experience in design control
- Strong experience in risk management
- Strong experience in CAPA
- Strong experience in change control
- Strong experience in design transfer
- Sound knowledge of EU MDR
- Sound knowledge of FDA Quality System Regulation
- Sound knowledge of ISO 13485
- Sound knowledge of ISO 14971
- Sound knowledge of IEC 60601
- Experience with ALM/PLM tools
- Experience with quality-management tools
- Experience leading cross-functional teams
- Experience leading external partners
- Experience leading budgets
- Experience leading multiple concurrent development projects
- Strong analytical skills
- Strong problem-solving skills
- Ability to interpret complex standards and regulations
- Strong communication skills
- Strong stakeholder management skills
- Ability to challenge design decisions constructively
- Cross-functional collaboration mindset
- Structured working style
- Detail-oriented working style
Aufgaben
- Provide leadership for Systems Engineering and Quality Engineering teams
- Set team objectives, priorities, roles, and capacity plans
- Develop employee performance and capabilities
- Support recruiting and onboarding new employees
- Build a culture of collaboration and accountability
- Plan and manage internal and external resources and budgets
- Own Systems Engineering processes from stakeholder needs to validation
- Ensure coherent system architecture and defined interfaces
- Lead requirements management and system integration
- Conduct technical reviews and trade-off decisions
- Lead technical problem solving
- Align system requirements with cross-functional teams
- Own risk-based Quality Engineering support for product development
- Ensure quality of design inputs, outputs, and reviews
- Oversee risk management, verification, and validation
- Monitor quality metrics and nonconformities
- Drive sustainable improvements for product quality
- Support audits, inspections, and regulatory submissions
- Create objective development evidence
- Represent Systems and Quality Engineering in governance meetings
- Define and improve shared processes, methods, and tools
- Ensure risk-based planning of reviews and integration
- Provide transparent reporting on progress and risks
- Resolve cross-functional conflicts
- Escalate critical product, quality, and resource risks
Berufserfahrung
10 Jahre
Ausbildung
Bachelor-AbschlussODER
Master-Abschluss
Sprachen
Englisch – verhandlungssicher
Tools & Technologien
EU MDRFDA Quality System RegulationISO 13485ISO 14971IEC 60601ALM/PLMCodebeamerPolarionDOORS
Benefits
Mentoring & Coaching
- Personal induction plan
Sonstige Vorteile
- Comprehensive onboarding
- Accident insurance
Flexibles Arbeiten
- Flexible working hours
Mehr Urlaubstage
- 30 days of holiday
Abwechslungsreiche Aufgaben
- Interesting tasks
Weiterbildungsangebote
- Continuous training and development
- Free language courses
Lockere Unternehmenskultur
- Flat hierarchies
Gratis oder Vergünstigte Mahlzeiten
- Attractive canteen
Snacks & Getränke
- Free coffee, tea and water
Team Events & Ausflüge
- Employee events
Fokus auf Nachhaltigkeit
- Charging stations for electric cars
Sonstige Zulagen
- Employer contribution to VWL
- Employee fund with allowances and subsidies
Von Nejo automatisch aufbereitet
Nejo hat diesen Job automatisch von der Website des Unternehmens Dornier MedTech erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Zur Originalanzeige bei Dornier MedTechÜber das Unternehmen
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HealthcareWeßling
Das Unternehmen ist ein Pionier auf dem Gebiet der Urologie und bietet innovative Medizinprodukte an.
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