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
Developing new aesthetic devices and combination products, integrating cross-disciplinary inputs for robust design. 5+ years product development expertise from concept to market 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 ensuring system design and documentation comply with safety and regulatory requirements
- 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 including user and stakeholder need definition
- Requirements definition
- Risk management
- Product architecture
- Configuration management
- Traceability
- Change management
- DHF management
- 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 working with third-party vendors
- Vendor communication and management
- Deliverable acceptance testing
- Intercultural competence in a global environment
- Experience with Aesthetic Filler products preferred
- Strong written and verbal communication skills
- Scientific writing
- 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
Aufgaben
- Contribute to the development of new aesthetic devices and combination products
- Integrate inputs and risks from multiple disciplines for robust product design
- Ensure systems are safe and effective for clinical and commercial development
- Drive implementation of Systems Engineering principles within Design Controls
- Define and manage user and stakeholder needs, use cases, and product requirements
- Lead system and use-related risk management activities
- Oversee and integrate third-party development activities
- Collaborate with cross-functional teams to identify and implement process improvements
- Standardize methods and ways of working to enhance consistency and efficiency
- Collaborate with cross-functional teams to plan and coordinate testing activities
- Serve as the dedicated systems engineer for projects
- Independently own key deliverables and coordinate stakeholder input
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
- Work-life balance
Gesundheits- & Fitnessangebote
- Corporate health management
Sonstige Vorteile
- Company social benefits
- Equality, equity, diversity and inclusion
Karriere- und Weiterentwicklung
- Career opportunities
Weiterbildungsangebote
- Development opportunities
Lockere Unternehmenskultur
- International network
- Great Place to Work recognition
Fokus auf Nachhaltigkeit
- Environmental and community focus
Von Nejo automatisch aufbereitet
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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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