Thoratec Switzerland GmbH
Senior Manufacturing Engineer(m/w/x)
Full-timeOn-siteSenior
Zürich
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THThoratec Switzerland GmbH
Manager NPI Engineering(m/w/x)
Zürich
Full-timeOn-siteSenior
Nejo AI Summary
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.
Requirements
- 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
Tasks
- 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
Work Experience
- 5 years
Education
- Vocational certification
Languages
- English – Business Fluent
- German – Business Fluent
Tools & Technologies
- ISO13485
- FDA21CFR820
- MDR
- GMP
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Thoratec Switzerland GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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THThoratec Switzerland GmbH
Manager NPI Engineering(m/w/x)
Zürich
Full-timeOn-siteSenior
Nejo AI Summary
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.
Requirements
- 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
Tasks
- 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
Work Experience
- 5 years
Education
- Vocational certification
Languages
- English – Business Fluent
- German – Business Fluent
Tools & Technologies
- ISO13485
- FDA21CFR820
- MDR
- GMP
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Thoratec Switzerland GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
Thoratec Switzerland GmbH
Industry
Healthcare
Description
The company is a global leader in life-saving medical technologies, supporting patients with advanced heart failure.
Not a perfect match?
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R&D Project Manager(m/w/x)
Full-timeOn-siteExperiencedZürich - HITACHI ENERGY LTD
Project Manager Secondary Engineering(m/w/x)
Full-timeOn-siteExperiencedZürich - SIEGFRIED DiNAMIQS AG
Head of Manufacturing and MSAT(m/w/x)
Full-timeOn-siteManagementSchlieren