Thoratec Switzerland GmbH
Senior Manufacturing Engineer(m/w/x)
Vollzeitnur vor OrtSenior
Zürich
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THThoratec Switzerland GmbH
Manager NPI Engineering(m/w/x)
Zürich
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Driving design transfer for life-saving mechanical circulatory support devices, leading a team of up to 8 engineers at a global medical device manufacturer. 5+ years MedTech experience, 3+ years people leadership, and strong regulatory knowledge (ISO13485/FDA21CFR820/MDR/GMP) required. Team building focus, cross-site coordination.
Anforderungen
- Master’s degree in science or engineering
- Minimum 5 years’ experience in NPI, industrialization, or product creation
- Minimum 5 years in MedTech or pharma
- Strong knowledge of ISO13485/FDA21CFR820/MDR/GMP
- Minimum 3 years of people leadership
- Strong project management experience (cross-functional and multi-site)
- Excellent communication skills
- Fluent English (negotiation level)
- Further education in business, project management, or leadership
- Fluent German
- Experience in fast-paced, regulated environments
- Structured, analytical mindset and collaborative working style
- Openness to diverse cultures and ways of working
Aufgaben
- Build an NPI team of up to 8 engineers
- Lead an NPI team of up to 8 engineers
- Define design transfer work packages compliant with procedures
- Estimate time and cost for design transfer
- Coordinate with cross-site program management
- Synchronize with R&D, supply chain, and quality engineering
- Collaborate with manufacturing, production, OPEX, and finance
- Ensure design for manufacturability, assembly, and test
- Prepare plans to set up new production lines
- Execute plans to qualify new production lines
- Define and implement processes for resource availability
- Define and implement processes for high product quality
- Perform risk analysis and reporting
- Conduct risk review boards
- Define mitigation actions
- Implement mitigation actions
- Establish efficient communication for commitments and deadlines
- Establish efficient communication to resolve issues
- Define KPIs for design transfer metrics
- Monitor KPIs for design transfer metrics
Berufserfahrung
- 5 Jahre
Ausbildung
- Abgeschlossene Berufsausbildung
Sprachen
- Englisch – verhandlungssicher
- Deutsch – verhandlungssicher
Tools & Technologien
- ISO13485
- FDA21CFR820
- MDR
- GMP
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Thoratec Switzerland GmbH 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.
Noch nicht perfekt?
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Vollzeitnur vor OrtBerufserfahrenZürich - HITACHI ENERGY LTD
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Vollzeitnur vor OrtBerufserfahrenZürich - HITACHI ENERGY LTD
Project Manager Secondary Engineering(m/w/x)
Vollzeitnur vor OrtBerufserfahrenZürich - SIEGFRIED DiNAMIQS AG
Head of Manufacturing and MSAT(m/w/x)
Vollzeitnur vor OrtManagementSchlieren
THThoratec Switzerland GmbH
Manager NPI Engineering(m/w/x)
Zürich
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Driving design transfer for life-saving mechanical circulatory support devices, leading a team of up to 8 engineers at a global medical device manufacturer. 5+ years MedTech experience, 3+ years people leadership, and strong regulatory knowledge (ISO13485/FDA21CFR820/MDR/GMP) required. Team building focus, cross-site coordination.
Anforderungen
- Master’s degree in science or engineering
- Minimum 5 years’ experience in NPI, industrialization, or product creation
- Minimum 5 years in MedTech or pharma
- Strong knowledge of ISO13485/FDA21CFR820/MDR/GMP
- Minimum 3 years of people leadership
- Strong project management experience (cross-functional and multi-site)
- Excellent communication skills
- Fluent English (negotiation level)
- Further education in business, project management, or leadership
- Fluent German
- Experience in fast-paced, regulated environments
- Structured, analytical mindset and collaborative working style
- Openness to diverse cultures and ways of working
Aufgaben
- Build an NPI team of up to 8 engineers
- Lead an NPI team of up to 8 engineers
- Define design transfer work packages compliant with procedures
- Estimate time and cost for design transfer
- Coordinate with cross-site program management
- Synchronize with R&D, supply chain, and quality engineering
- Collaborate with manufacturing, production, OPEX, and finance
- Ensure design for manufacturability, assembly, and test
- Prepare plans to set up new production lines
- Execute plans to qualify new production lines
- Define and implement processes for resource availability
- Define and implement processes for high product quality
- Perform risk analysis and reporting
- Conduct risk review boards
- Define mitigation actions
- Implement mitigation actions
- Establish efficient communication for commitments and deadlines
- Establish efficient communication to resolve issues
- Define KPIs for design transfer metrics
- Monitor KPIs for design transfer metrics
Berufserfahrung
- 5 Jahre
Ausbildung
- Abgeschlossene Berufsausbildung
Sprachen
- Englisch – verhandlungssicher
- Deutsch – verhandlungssicher
Tools & Technologien
- ISO13485
- FDA21CFR820
- MDR
- GMP
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Thoratec Switzerland GmbH 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.
Über das Unternehmen
Thoratec Switzerland GmbH
Branche
Healthcare
Beschreibung
The company is a global leader in life-saving medical technologies, supporting patients with advanced heart failure.
Noch nicht perfekt?
- Thoratec Switzerland GmbH
Senior Manufacturing Engineer(m/w/x)
Vollzeitnur vor OrtSeniorZürich - Abbott Laboratories GmbH
Technical Writer – Medical Device(m/w/x)
Vollzeitnur vor OrtBerufserfahrenZürich - HITACHI ENERGY LTD
R&D Project Manager(m/w/x)
Vollzeitnur vor OrtBerufserfahrenZürich - HITACHI ENERGY LTD
Project Manager Secondary Engineering(m/w/x)
Vollzeitnur vor OrtBerufserfahrenZürich - SIEGFRIED DiNAMIQS AG
Head of Manufacturing and MSAT(m/w/x)
Vollzeitnur vor OrtManagementSchlieren