Roche
Medical Device Platform Design Engineer(m/w/x)
Vollzeitnur vor OrtBerufserfahren
Basel
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
RORoche
Medical Device Platform Technical Lead(m/w/x)
Basel
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Leading technical teams for autoinjector and PFS-needle safety device platforms. Systems engineering fundamentals and mechanical product design expertise required. Personal expression encouraged, fostering genuine connections.
Anforderungen
- Expertise in systems engineering fundamentals
- Mechanical product and process design
- Collaborative operation in cross-functional teams
- Systems-level perspective
- Integration of device constituents and container closure systems
- Compliance with regulatory and quality standards
- Delivery of safe, effective, scalable drug delivery devices
- BS in Mechanical Engineering or equivalent technical degree
- In-depth understanding of prefilled syringes
- In-depth understanding of Autoinjector
- In-depth understanding of PFS-Needle Safety Device
- In-depth understanding of novel drug delivery design and manufacturing
- Technical expertise in device development
- Technical expertise in integrated combination product development
- Comprehensive understanding of pharmaceutical processes
- Comprehensive understanding of delivery system processes
- Knowledge of Medical Device regulations
- Experience with Requirement Management
- Experience with Requirement Hierarchies
- Experience with Requirement Traceability
- Experience with Requirement Authorship
- Experience with Platform vs Variant modalities
- Experience with systems engineering fundamentals
- Experience with continuous improvement methods and toolsets
- Excellent communication skills
- Excellent interpersonal skills
- Excellent collaboration skills
- Ability to engage with cross-functional teams
- Ability to engage with external suppliers
- Ability to engage with industry partners
- Ability to influence across scientific disciplines
- Ability to influence across organizational boundaries
- Entrepreneurial spirit
- Hands-on, roll-up-your-sleeves approach
- High sense of urgency
- Dedication to drive for results
Aufgaben
- Lead technical teams in developing Autoinjector and/or PFS-Needle Safety Device platforms
- Maintain Autoinjector and/or PFS-Needle Safety Device platforms
- Lead cross-functional technical teams for drug delivery platforms
- Develop and maintain robust drug delivery platforms
- Drive design excellence across diverse device platform technologies
- Lead Platform Technology teams in creating the Platform Design History File (DHF)
- Maintain the Platform Design History File (DHF)
- Collaborate with teams to develop Platform DHF elements
- Collaborate with teams to maintain Platform DHF elements
- Develop required Platform DHF documents
- Lead platform initiatives supporting product design and development
- Strategically plan platform data leverage plans
- Implement platform data leverage plans
- Provide platform technical support for E2E project activities
- Work with global cross-functional teams on development principles
- Broaden understanding of product and platform development principles
- Foster relationships with third-party development partners
- Provide technical expertise in systems engineering principles
- Define user and stakeholder needs
- Define requirements
- Manage risk for platform devices
- Define product architecture for platform devices
- Manage configuration for platform devices
- Ensure traceability for platform devices
- Manage change for platform devices
- Ensure reliability for platform devices
- Develop phase-appropriate platform-based verification methodologies
- Harmonize phase-appropriate platform-based verification methodologies
- Streamline phase-appropriate platform-based verification methodologies
- Develop phase-appropriate platform-based testing methodologies
- Harmonize phase-appropriate platform-based testing methodologies
- Streamline phase-appropriate platform-based testing methodologies
- Collaborate with regulatory teams on compliance
- Prepare technical documentation for regulatory submissions
- Review technical documentation for regulatory submissions
- Prepare technical documentation for regulatory audits
- Review technical documentation for regulatory audits
- Manage CDMO relationships for platform focused design
- Manage CDMO relationships for device platforms
Berufserfahrung
- 10 Jahre
Ausbildung
- Abgeschlossene BerufsausbildungODER
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- Requirement Management
- Requirement Hierarchies
- Requirement Traceability
- Requirement Authorship
- Platform vs Variant modalities
- systems engineering fundamentals
- continuous improvement methods
- continuous improvement toolsets
Benefits
Lockere Unternehmenskultur
- Personal expression encouraged
- Open dialogue encouraged
- Genuine connections fostered
- Valued, accepted, and respected
- Creativity fostered
Mentoring & Coaching
- Personal and professional thriving
Sinnstiftende Arbeit
- Empowerment to explore possibilities
Sonstige Vorteile
- High ambitions supported
Gesundheits- & Fitnessangebote
- Life-changing healthcare solutions delivery
Gemeinnützige Ausrichtung
- Global impact
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Roche 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.
Noch nicht perfekt?
- Roche
Medical Device Platform Lead - Autoinjector(m/w/x)
Vollzeitnur vor OrtSeniorBasel - F. Hoffmann-La Roche AG
Senior Device Engineer with Pen- / Autoinjector expertise(m/w/x)
Vollzeitnur vor OrtSeniorBasel - Roche
Principal Device Engineer with Pen- / Autoinjector expertise(m/w/x)
Vollzeitnur vor OrtSeniorBasel - 1201 F. Hoffmann-La Roche AG
Senior Device Engineer(m/w/x)
Vollzeitnur vor OrtManagementBasel
RORoche
Medical Device Platform Technical Lead(m/w/x)
Basel
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Leading technical teams for autoinjector and PFS-needle safety device platforms. Systems engineering fundamentals and mechanical product design expertise required. Personal expression encouraged, fostering genuine connections.
Anforderungen
- Expertise in systems engineering fundamentals
- Mechanical product and process design
- Collaborative operation in cross-functional teams
- Systems-level perspective
- Integration of device constituents and container closure systems
- Compliance with regulatory and quality standards
- Delivery of safe, effective, scalable drug delivery devices
- BS in Mechanical Engineering or equivalent technical degree
- In-depth understanding of prefilled syringes
- In-depth understanding of Autoinjector
- In-depth understanding of PFS-Needle Safety Device
- In-depth understanding of novel drug delivery design and manufacturing
- Technical expertise in device development
- Technical expertise in integrated combination product development
- Comprehensive understanding of pharmaceutical processes
- Comprehensive understanding of delivery system processes
- Knowledge of Medical Device regulations
- Experience with Requirement Management
- Experience with Requirement Hierarchies
- Experience with Requirement Traceability
- Experience with Requirement Authorship
- Experience with Platform vs Variant modalities
- Experience with systems engineering fundamentals
- Experience with continuous improvement methods and toolsets
- Excellent communication skills
- Excellent interpersonal skills
- Excellent collaboration skills
- Ability to engage with cross-functional teams
- Ability to engage with external suppliers
- Ability to engage with industry partners
- Ability to influence across scientific disciplines
- Ability to influence across organizational boundaries
- Entrepreneurial spirit
- Hands-on, roll-up-your-sleeves approach
- High sense of urgency
- Dedication to drive for results
Aufgaben
- Lead technical teams in developing Autoinjector and/or PFS-Needle Safety Device platforms
- Maintain Autoinjector and/or PFS-Needle Safety Device platforms
- Lead cross-functional technical teams for drug delivery platforms
- Develop and maintain robust drug delivery platforms
- Drive design excellence across diverse device platform technologies
- Lead Platform Technology teams in creating the Platform Design History File (DHF)
- Maintain the Platform Design History File (DHF)
- Collaborate with teams to develop Platform DHF elements
- Collaborate with teams to maintain Platform DHF elements
- Develop required Platform DHF documents
- Lead platform initiatives supporting product design and development
- Strategically plan platform data leverage plans
- Implement platform data leverage plans
- Provide platform technical support for E2E project activities
- Work with global cross-functional teams on development principles
- Broaden understanding of product and platform development principles
- Foster relationships with third-party development partners
- Provide technical expertise in systems engineering principles
- Define user and stakeholder needs
- Define requirements
- Manage risk for platform devices
- Define product architecture for platform devices
- Manage configuration for platform devices
- Ensure traceability for platform devices
- Manage change for platform devices
- Ensure reliability for platform devices
- Develop phase-appropriate platform-based verification methodologies
- Harmonize phase-appropriate platform-based verification methodologies
- Streamline phase-appropriate platform-based verification methodologies
- Develop phase-appropriate platform-based testing methodologies
- Harmonize phase-appropriate platform-based testing methodologies
- Streamline phase-appropriate platform-based testing methodologies
- Collaborate with regulatory teams on compliance
- Prepare technical documentation for regulatory submissions
- Review technical documentation for regulatory submissions
- Prepare technical documentation for regulatory audits
- Review technical documentation for regulatory audits
- Manage CDMO relationships for platform focused design
- Manage CDMO relationships for device platforms
Berufserfahrung
- 10 Jahre
Ausbildung
- Abgeschlossene BerufsausbildungODER
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- Requirement Management
- Requirement Hierarchies
- Requirement Traceability
- Requirement Authorship
- Platform vs Variant modalities
- systems engineering fundamentals
- continuous improvement methods
- continuous improvement toolsets
Benefits
Lockere Unternehmenskultur
- Personal expression encouraged
- Open dialogue encouraged
- Genuine connections fostered
- Valued, accepted, and respected
- Creativity fostered
Mentoring & Coaching
- Personal and professional thriving
Sinnstiftende Arbeit
- Empowerment to explore possibilities
Sonstige Vorteile
- High ambitions supported
Gesundheits- & Fitnessangebote
- Life-changing healthcare solutions delivery
Gemeinnützige Ausrichtung
- Global impact
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Roche 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
Roche
Branche
Healthcare
Beschreibung
The company is dedicated to advancing science and ensuring access to healthcare for everyone.
Noch nicht perfekt?
- Roche
Medical Device Platform Design Engineer(m/w/x)
Vollzeitnur vor OrtBerufserfahrenBasel - Roche
Medical Device Platform Lead - Autoinjector(m/w/x)
Vollzeitnur vor OrtSeniorBasel - F. Hoffmann-La Roche AG
Senior Device Engineer with Pen- / Autoinjector expertise(m/w/x)
Vollzeitnur vor OrtSeniorBasel - Roche
Principal Device Engineer with Pen- / Autoinjector expertise(m/w/x)
Vollzeitnur vor OrtSeniorBasel - 1201 F. Hoffmann-La Roche AG
Senior Device Engineer(m/w/x)
Vollzeitnur vor OrtManagementBasel