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SHSHL Medical
Business Process Manager Hardware Verification & DFM(m/w/x)
Zug
Vollzeitmit HomeofficeSenior
Nejo KI-Zusammenfassung
Designing and implementing business processes for hardware verification and DFM in medical devices. 7+ years of process management experience in the medical device industry required. Flexible hours, hybrid work, and a multicultural team.
Anforderungen
- 7+ years of relevant experience in process management
- Success in process management within medical device/pharma industry
- Strong knowledge of hardware product development
- Strong knowledge of Verification processes
- Strong knowledge of Design Controls
- Strong knowledge of DFM principles
- Excellent strategic thinking capabilities
- Excellent problem-solving capabilities
- Excellent analytical capabilities
- Focus on continuous improvement
- Focus on innovation
- Ability to influence across organizational levels
- Ability to communicate effectively across organizational levels
- Promoting transparency
- Promoting collaboration
- Ability to work in fast-paced environment
- Ability to work in global environment
- Ability to work with multiple priorities
- Bachelor’s or Master’s degree in Engineering, Quality Management, Industrial Engineering or related field
- Fluency in English
- Familiarity with PLM systems
- Familiarity with digital documentation workflows
- Experience applying agile methodologies in process design
- Certification in Lean Six Sigma, Process Management or Project Management (e.g. PMI, IPMA) is a plus
- Training in DFM methodologies preferred
- Training in Verification standards preferred
- Experience with ISO 13485
- Experience with FDA regulations
- Experience with similar compliance frameworks
- German skills are a plus
Aufgaben
- Design, implement, and improve business processes for Design Verification and DFM
- Ensure compliance with regulatory and quality standards
- Collaborate with R&D, Quality, Regulatory, Manufacturing, Operations, and IT
- Harmonize processes and documentation with production requirements
- Develop and maintain process documentation and training materials
- Conduct workshops and training sessions to identify process gaps
- Support change management initiatives
- Translate business needs into functional solutions
- Implement and validate PLM solutions with system architects
- Monitor process performance and report KPIs
- Collect user feedback for continuous improvement
Berufserfahrung
- 7 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – fließend
- Deutsch – Grundkenntnisse
Tools & Technologien
- PLM systems
- Signavio
- ISO 13485
- FDA regulations
Benefits
Flexibles Arbeiten
- Flexible hours
- Hybrid working policy
Lockere Unternehmenskultur
- Multicultural team
- Inclusive environment
- Collaborative environment
- Sense of belonging
Modernes Büro
- Modern working environment
- State-of-the-art facilities
Moderne Technikausstattung
- State-of-the-art technologies
Sinnstiftende Arbeit
- Meaningful exchange
Sonstige Vorteile
- Shared growth
Weiterbildungsangebote
- Personal development opportunities
- Professional development opportunities
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens SHL Medical 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.
SHSHL Medical
Business Process Manager Hardware Verification & DFM(m/w/x)
Zug
Vollzeitmit HomeofficeSenior
Nejo KI-Zusammenfassung
Designing and implementing business processes for hardware verification and DFM in medical devices. 7+ years of process management experience in the medical device industry required. Flexible hours, hybrid work, and a multicultural team.
Anforderungen
- 7+ years of relevant experience in process management
- Success in process management within medical device/pharma industry
- Strong knowledge of hardware product development
- Strong knowledge of Verification processes
- Strong knowledge of Design Controls
- Strong knowledge of DFM principles
- Excellent strategic thinking capabilities
- Excellent problem-solving capabilities
- Excellent analytical capabilities
- Focus on continuous improvement
- Focus on innovation
- Ability to influence across organizational levels
- Ability to communicate effectively across organizational levels
- Promoting transparency
- Promoting collaboration
- Ability to work in fast-paced environment
- Ability to work in global environment
- Ability to work with multiple priorities
- Bachelor’s or Master’s degree in Engineering, Quality Management, Industrial Engineering or related field
- Fluency in English
- Familiarity with PLM systems
- Familiarity with digital documentation workflows
- Experience applying agile methodologies in process design
- Certification in Lean Six Sigma, Process Management or Project Management (e.g. PMI, IPMA) is a plus
- Training in DFM methodologies preferred
- Training in Verification standards preferred
- Experience with ISO 13485
- Experience with FDA regulations
- Experience with similar compliance frameworks
- German skills are a plus
Aufgaben
- Design, implement, and improve business processes for Design Verification and DFM
- Ensure compliance with regulatory and quality standards
- Collaborate with R&D, Quality, Regulatory, Manufacturing, Operations, and IT
- Harmonize processes and documentation with production requirements
- Develop and maintain process documentation and training materials
- Conduct workshops and training sessions to identify process gaps
- Support change management initiatives
- Translate business needs into functional solutions
- Implement and validate PLM solutions with system architects
- Monitor process performance and report KPIs
- Collect user feedback for continuous improvement
Berufserfahrung
- 7 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – fließend
- Deutsch – Grundkenntnisse
Tools & Technologien
- PLM systems
- Signavio
- ISO 13485
- FDA regulations
Benefits
Flexibles Arbeiten
- Flexible hours
- Hybrid working policy
Lockere Unternehmenskultur
- Multicultural team
- Inclusive environment
- Collaborative environment
- Sense of belonging
Modernes Büro
- Modern working environment
- State-of-the-art facilities
Moderne Technikausstattung
- State-of-the-art technologies
Sinnstiftende Arbeit
- Meaningful exchange
Sonstige Vorteile
- Shared growth
Weiterbildungsangebote
- Personal development opportunities
- Professional development opportunities
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens SHL Medical 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
SHL Medical
Branche
Healthcare
Beschreibung
Das Unternehmen ist ein weltweit führender Anbieter im Design, der Entwicklung und der Herstellung fortschrittlicher Selbstinjektionsgeräte.