Xylem Analytics Germany GmbH
Projektleiter F&E / R&D, Technical Product Owner(m/w/x)
Vollzeitmit HomeofficeSenior
Mainz
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
COColoplast A/S
Product Lifecycle Manager - Medical Device(m/w/x)
Nieder-Olm
Vollzeitmit HomeofficeBerufserfahren
Nejo KI-Zusammenfassung
Managing product lifecycle and design changes for tracheostomy devices, ensuring regulatory compliance with EU-MDR and 21 CFR 820. At least 3 years in medical devices and QMS experience required. Flexible working hours and mobile working up to 2 days per week.
Anforderungen
- Bachelor’s degree in technical or scientific field
- At least 3 years experience in medical device or life-science industry
- Proven experience managing complex, cross-functional projects
- Practical experience in regulated environment (EN ISO 13485, EU-MDR, 21 CFR 820, MDSAP, ISO 14971, IEC 62366)
- Experience working within a quality management system
- Confident use of MS Office 365
- Strong quality mindset
- Ability to pragmatically implement technical, regulatory, documentation requirements
- Experience working in an international environment
- Analytical, structured, solution-oriented working style
- High level of initiative
- Sense of responsibility
- Reliability
- Holistic thinking
- Openness to new perspectives
- Bachelor’s degree in technical or scientific field
- At least 3 years experience in medical device or life-science industry
- Proven experience managing complex, cross-functional projects
- Practical experience in regulated environment (EN ISO 13485, EU-MDR, 21 CFR 820, MDSAP, ISO 14971, IEC 62366)
- Experience working within a quality management system
- Confident use of MS Office 365
- Strong quality mindset
- Ability to pragmatically implement technical, regulatory, documentation requirements
- Experience working in an international environment
- Analytical, structured, solution-oriented working style
- High level of initiative
- Sense of responsibility
- Reliability
- Holistic thinking
- Openness to new perspectives
Aufgaben
- Manage product and design changes throughout lifecycle
- Create regulatory-compliant documentation (EN ISO 13485, EU-MDR, 21 CFR 820, MDSAP)
- Maintain and develop Design History Files (DHF)
- Update technical documentation for medical devices (classes Is/m to IIa/b)
- Ensure traceability from user needs to design inputs/outputs
- Conduct verification, validation, and risk management
- Serve as technical point of contact for Design Control & Lifecycle Management
- Contribute to quality activities (risk management, CAPAs, complaints, non-conformances, post-market topics)
- Plan and support transfer of new developments and product changes to production
- Participate in design reviews with focus on lifecycle and compliance
- Support audits and inspections
- Contribute to continuous improvement of lifecycle management processes
Berufserfahrung
- 3 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – fortgeschritten
Tools & Technologien
- MS Office 365
- EN ISO 13485
- EU-MDR
- 21 CFR 820
- MDSAP
- ISO 14971
- IEC 62366
Benefits
Flexibles Arbeiten
- Flexible working time models
- Flexitime
- Mobile working (up to 2 days per week)
Sicherer Arbeitsplatz
- Secure and responsible position
Lockere Unternehmenskultur
- Successful and international team
- Welcoming culture
- Friendly working atmosphere
- Colleagues at eye level
Mentoring & Coaching
- Structured onboarding
- Active support for professional and personal development
Sonstige Vorteile
- Idea management
Startup-Atmosphäre
- Room to shape processes
Sinnstiftende Arbeit
- Independent work
Weiterbildungsangebote
- Internal and external training opportunities
Team Events & Ausflüge
- Company events
Parkplatz & Pendelvorteile
- Free parking
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Coloplast A/S 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.
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Managing product lifecycle and design changes for tracheostomy devices, ensuring regulatory compliance with EU-MDR and 21 CFR 820. At least 3 years in medical devices and QMS experience required. Flexible working hours and mobile working up to 2 days per week.
Anforderungen
- Bachelor’s degree in technical or scientific field
- At least 3 years experience in medical device or life-science industry
- Proven experience managing complex, cross-functional projects
- Practical experience in regulated environment (EN ISO 13485, EU-MDR, 21 CFR 820, MDSAP, ISO 14971, IEC 62366)
- Experience working within a quality management system
- Confident use of MS Office 365
- Strong quality mindset
- Ability to pragmatically implement technical, regulatory, documentation requirements
- Experience working in an international environment
- Analytical, structured, solution-oriented working style
- High level of initiative
- Sense of responsibility
- Reliability
- Holistic thinking
- Openness to new perspectives
- Bachelor’s degree in technical or scientific field
- At least 3 years experience in medical device or life-science industry
- Proven experience managing complex, cross-functional projects
- Practical experience in regulated environment (EN ISO 13485, EU-MDR, 21 CFR 820, MDSAP, ISO 14971, IEC 62366)
- Experience working within a quality management system
- Confident use of MS Office 365
- Strong quality mindset
- Ability to pragmatically implement technical, regulatory, documentation requirements
- Experience working in an international environment
- Analytical, structured, solution-oriented working style
- High level of initiative
- Sense of responsibility
- Reliability
- Holistic thinking
- Openness to new perspectives
Aufgaben
- Manage product and design changes throughout lifecycle
- Create regulatory-compliant documentation (EN ISO 13485, EU-MDR, 21 CFR 820, MDSAP)
- Maintain and develop Design History Files (DHF)
- Update technical documentation for medical devices (classes Is/m to IIa/b)
- Ensure traceability from user needs to design inputs/outputs
- Conduct verification, validation, and risk management
- Serve as technical point of contact for Design Control & Lifecycle Management
- Contribute to quality activities (risk management, CAPAs, complaints, non-conformances, post-market topics)
- Plan and support transfer of new developments and product changes to production
- Participate in design reviews with focus on lifecycle and compliance
- Support audits and inspections
- Contribute to continuous improvement of lifecycle management processes
Berufserfahrung
- 3 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – fortgeschritten
Tools & Technologien
- MS Office 365
- EN ISO 13485
- EU-MDR
- 21 CFR 820
- MDSAP
- ISO 14971
- IEC 62366
Benefits
Flexibles Arbeiten
- Flexible working time models
- Flexitime
- Mobile working (up to 2 days per week)
Sicherer Arbeitsplatz
- Secure and responsible position
Lockere Unternehmenskultur
- Successful and international team
- Welcoming culture
- Friendly working atmosphere
- Colleagues at eye level
Mentoring & Coaching
- Structured onboarding
- Active support for professional and personal development
Sonstige Vorteile
- Idea management
Startup-Atmosphäre
- Room to shape processes
Sinnstiftende Arbeit
- Independent work
Weiterbildungsangebote
- Internal and external training opportunities
Team Events & Ausflüge
- Company events
Parkplatz & Pendelvorteile
- Free parking
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Coloplast A/S 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.
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
Über das Unternehmen
Coloplast A/S
Branche
Pharmaceuticals
Beschreibung
Das Unternehmen entwickelt und vermarktet Produkte und Dienstleistungen, die das Leben von Menschen mit persönlichen medizinischen Bedürfnissen vereinfachen.
Noch nicht perfekt?
- Xylem Analytics Germany GmbH
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Vollzeitmit HomeofficeSeniorMainz - SCHOTT Pharma AG & Co. KGaA
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Vollzeitmit HomeofficeBerufserfahrenMainz - Coloplast A/S
Technischer Einkäufer - Medizintechnik / Technical Purchaser - medical devices Operativer Einkäufer / Operational Purchaser - Medizintechnik(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenNieder-Olm - Coloplast A/S
Praktikant / Intern R&D - Medical Device Development(m/w/x)
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