Xylem Analytics Germany GmbH
Projektleiter F&E / R&D, Technical Product Owner(m/w/x)
Full-timeWith HomeofficeSenior
Mainz
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COColoplast A/S
Product Lifecycle Manager - Medical Device(m/w/x)
Nieder-Olm
Full-timeWith Home OfficeExperienced
Nejo AI Summary
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.
Requirements
- 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
Tasks
- 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
Work Experience
- 3 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
- German – Advanced
Tools & Technologies
- MS Office 365
- EN ISO 13485
- EU-MDR
- 21 CFR 820
- MDSAP
- ISO 14971
- IEC 62366
Benefits
Flexible Working
- Flexible working time models
- Flexitime
- Mobile working (up to 2 days per week)
Job Security
- Secure and responsible position
Informal Culture
- Successful and international team
- Welcoming culture
- Friendly working atmosphere
- Colleagues at eye level
Mentorship & Coaching
- Structured onboarding
- Active support for professional and personal development
Other Benefits
- Idea management
Startup Environment
- Room to shape processes
Purpose-Driven Work
- Independent work
Learning & Development
- Internal and external training opportunities
Team Events
- Company events
Parking & Commuter Benefits
- Free parking
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Coloplast A/S 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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COColoplast A/S
Product Lifecycle Manager - Medical Device(m/w/x)
Nieder-Olm
Full-timeWith Home OfficeExperienced
Nejo AI Summary
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.
Requirements
- 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
Tasks
- 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
Work Experience
- 3 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
- German – Advanced
Tools & Technologies
- MS Office 365
- EN ISO 13485
- EU-MDR
- 21 CFR 820
- MDSAP
- ISO 14971
- IEC 62366
Benefits
Flexible Working
- Flexible working time models
- Flexitime
- Mobile working (up to 2 days per week)
Job Security
- Secure and responsible position
Informal Culture
- Successful and international team
- Welcoming culture
- Friendly working atmosphere
- Colleagues at eye level
Mentorship & Coaching
- Structured onboarding
- Active support for professional and personal development
Other Benefits
- Idea management
Startup Environment
- Room to shape processes
Purpose-Driven Work
- Independent work
Learning & Development
- Internal and external training opportunities
Team Events
- Company events
Parking & Commuter Benefits
- Free parking
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Coloplast A/S 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.
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
Coloplast A/S
Industry
Pharmaceuticals
Description
Das Unternehmen entwickelt und vermarktet Produkte und Dienstleistungen, die das Leben von Menschen mit persönlichen medizinischen Bedürfnissen vereinfachen.
Not a perfect match?
- Xylem Analytics Germany GmbH
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Full-timeWith HomeofficeSeniorMainz - Coloplast A/S
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Full-timeWith HomeofficeExperiencedNieder-Olm - SpiraTec
Projektmanager Validierung(m/w/x)
Full-timeWith HomeofficeSeniorIngelheim am Rhein - CNT Management Consulting
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Full-timeWith HomeofficeSeniorMainz, München, Hamburg