AbbVie
Senior Systems Engineer – Aesthetic Filler & Combination Products (m/w/x)
Vollzeitmit HomeofficeSenior
Ludwigshafen am Rhein
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ABAbbVie
Senior Systems Engineer – Aesthetic Filler & Combination Products (m/w/x)
Vollzeitmit HomeofficeSenior
Nejo KI-Zusammenfassung
Driving system architecture and integration for aesthetic filler combination products. 7+ years engineering experience with product development expertise required. Flexible work models, corporate health management.
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Anforderungen
- Bachelor’s degree in Engineering, Science, or related discipline with 7+ years experience, or Master’s degree with 5+ years experience
- Technical leadership for system design and documentation compliance
- Product development expertise from concept to market
- Direct experience in combination product or medical device development
- Familiarity with FDA 21 CFR Part 820.30, 21 CFR Part 4, ISO14971, ISO 13485 and EU MDR preferred
- Systems Engineering principles expertise
- User and stakeholder need definition
- Requirements definition
- Risk management
- Product architecture
- Configuration management
- Traceability
- Change management
- DHF management expertise
- Creating Design Control documents in compliance with regulations
- Analytical and problem-solving skills
- Ability to resolve key project challenges
- Sound decision making
- Risk identification and mitigation planning
- Experience with third-party vendors
- Vendor communication, management, and deliverable acceptance testing
- Intercultural competence in a global environment
- Experience with Aesthetic Filler products preferred
- Strong written and verbal communication skills
- Scientific writing skills
- Self-driven and structured approach to managing priorities and timelines
- Excellent written and oral communication skills in English
- Excellent written and oral communication skills in German
- Willingness to travel internationally
Aufgaben
- Drive implementation of Systems Engineering principles within Design Controls
- Focus on system architecture and integration
- Manage Design Inputs, traceability, risk management, and change management
- Oversee DHF architecture
- Define and manage user and stakeholder needs
- Define and manage use cases and product requirements
- Define and manage applicable standards throughout the product development lifecycle
- Lead system and use-related risk management activities
- Lead risk planning and reporting
- Lead system risk assessments
- Lead design and process FMEAs
- Oversee and integrate third-party development activities
- Ensure alignment of Design Control and Quality by Design activities
- Collaborate with cross-functional teams to identify process gaps
- Recommend and implement process improvements
- Standardize methods and ways of working
- Enhance consistency, efficiency, and operational effectiveness
- Develop sustainable business and organizational strategies
- Collaborate with cross-functional teams to plan and coordinate testing activities
- Manage sample and laboratory resource planning
- Drive improvements to processes and methods
- Serve as the dedicated systems engineer for projects
- Independently own key deliverables
- Coordinate stakeholder input for successful execution
Berufserfahrung
5 Jahre
Ausbildung
Bachelor-AbschlussODER
Master-Abschluss
Sprachen
Englisch – verhandlungssicher
Deutsch – verhandlungssicher
Tools & Technologien
FDA 21 CFR Part 820.3021 CFR Part 4ISO14971ISO 13485EU MDR
Benefits
Flexibles Arbeiten
- Flexible work models
Gesundheits- & Fitnessangebote
- Corporate health management
- Health programs
- Exercise programs
Sonstige Vorteile
- Company social benefits
Karriere- und Weiterentwicklung
- Career opportunities
Weiterbildungsangebote
- Development opportunities
Lockere Unternehmenskultur
- International network
Von Nejo automatisch aufbereitet
Nejo hat diesen Job automatisch von der Website des Unternehmens AbbVie 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.
Zur Originalanzeige bei AbbVieÜber das Unternehmen
AB
PharmaceuticalsLudwigshafen am Rhein
Das Unternehmen setzt sich für die Entdeckung und Bereitstellung innovativer Medikamente und Lösungen ein, die ernsthafte Gesundheitsprobleme lösen.
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