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Device Technology Deployment Manager(m/w/x)
Deploying and industrializing new medical device equipment and packaging technologies. 7+ years technical project management experience in regulated environments required. Company car for private use, 6 weeks vacation.
Anforderungen
- Bachelor's or Master's degree in Engineering, Science, or related technical field
- 7+ years technical Project Management experience (CAPEX-projects)
- Experience deploying, industrializing, and qualifying new equipment/technologies
- Expertise in supplier management, URS, machine risk assessments, C&Q strategies
- Experience in highly regulated environment (Medical Device/Pharmaceutical)
- Solid understanding of cGMP, ISO standards, FDA regulations
- Deep knowledge of medical device manufacturing processes
- Hands-on experience in Device Assembly, Final Sterilization, or Final Packaging
- Lead and support process development and technology scaling
- Familiarity with Automation/MES systems (advantageous)
- Exceptional communication, negotiation, and influencing skills
- Fluent in English
- Willingness to travel internationally (up to 25%)
- PMP or other recognized certification (highly desirable)
Aufgaben
- Lead end-to-end device and packaging technology deployment projects
- Execute end-to-end device and packaging technology deployment projects
- Drive strategic equipment initiatives
- Drive strategic process initiatives
- Enhance product robustness
- Enhance product efficiency
- Enhance product future-readiness
- Introduce novel technologies across the product lifecycle
- Own the technology lifecycle from concept assessment
- Own the technology lifecycle through pilot execution
- Own the technology lifecycle through large-scale deployment
- Evaluate feasibility
- Evaluate scalability
- Evaluate implementation readiness
- Proactively identify risks
- Implement effective mitigation strategies
- Oversee critical equipment acceptance protocols
- Execute critical equipment acceptance protocols
- Coordinate user engagement for acceptance protocols
- Ensure compliance with regulated standards
- Ensure timely review of design deliverables
- Ensure timely approval of design deliverables
- Ensure timely review of qualification deliverables
- Ensure timely approval of qualification deliverables
- Ensure timely review of validation deliverables
- Ensure timely approval of validation deliverables
- Partner with Site Engineering on deliverables
- Partner with Quality on deliverables
- Partner with Device Development on deliverables
- Partner with MSAT on deliverables
- Partner with User teams on deliverables
- Ensure seamless cross-functional coordination
- Ensure alignment among key project stakeholders
- Manage the full supplier relationship lifecycle
- Select suppliers
- Engage suppliers via contract
- Monitor supplier performance
- Review critical technical documentation from suppliers
Berufserfahrung
- 7 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- Automation/MES systems
Gefällt dir diese Stelle?
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Device Technology Deployment Manager(m/w/x)
Deploying and industrializing new medical device equipment and packaging technologies. 7+ years technical project management experience in regulated environments required. Company car for private use, 6 weeks vacation.
Anforderungen
- Bachelor's or Master's degree in Engineering, Science, or related technical field
- 7+ years technical Project Management experience (CAPEX-projects)
- Experience deploying, industrializing, and qualifying new equipment/technologies
- Expertise in supplier management, URS, machine risk assessments, C&Q strategies
- Experience in highly regulated environment (Medical Device/Pharmaceutical)
- Solid understanding of cGMP, ISO standards, FDA regulations
- Deep knowledge of medical device manufacturing processes
- Hands-on experience in Device Assembly, Final Sterilization, or Final Packaging
- Lead and support process development and technology scaling
- Familiarity with Automation/MES systems (advantageous)
- Exceptional communication, negotiation, and influencing skills
- Fluent in English
- Willingness to travel internationally (up to 25%)
- PMP or other recognized certification (highly desirable)
Aufgaben
- Lead end-to-end device and packaging technology deployment projects
- Execute end-to-end device and packaging technology deployment projects
- Drive strategic equipment initiatives
- Drive strategic process initiatives
- Enhance product robustness
- Enhance product efficiency
- Enhance product future-readiness
- Introduce novel technologies across the product lifecycle
- Own the technology lifecycle from concept assessment
- Own the technology lifecycle through pilot execution
- Own the technology lifecycle through large-scale deployment
- Evaluate feasibility
- Evaluate scalability
- Evaluate implementation readiness
- Proactively identify risks
- Implement effective mitigation strategies
- Oversee critical equipment acceptance protocols
- Execute critical equipment acceptance protocols
- Coordinate user engagement for acceptance protocols
- Ensure compliance with regulated standards
- Ensure timely review of design deliverables
- Ensure timely approval of design deliverables
- Ensure timely review of qualification deliverables
- Ensure timely approval of qualification deliverables
- Ensure timely review of validation deliverables
- Ensure timely approval of validation deliverables
- Partner with Site Engineering on deliverables
- Partner with Quality on deliverables
- Partner with Device Development on deliverables
- Partner with MSAT on deliverables
- Partner with User teams on deliverables
- Ensure seamless cross-functional coordination
- Ensure alignment among key project stakeholders
- Manage the full supplier relationship lifecycle
- Select suppliers
- Engage suppliers via contract
- Monitor supplier performance
- Review critical technical documentation from suppliers
Berufserfahrung
- 7 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- Automation/MES systems
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
Über das Unternehmen
Roche
Branche
Pharmaceuticals
Beschreibung
The company is dedicated to advancing science and ensuring access to healthcare for everyone.
Noch nicht perfekt?
- F. Hoffmann-La Roche AG
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Group Lead Device Process Engineering - Global MSAT(m/w/x)
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