AbbVie
Senior Systems Engineer(m/w/x)
Vollzeitmit HomeofficeSenior
Ludwigshafen am Rhein
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Driving Systems Engineering in Design Controls for innovative medicines. Technical leadership and product development expertise from concept to market required. Flexible work models, intensive onboarding with mentor.
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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
- Combination product or medical device development experience
- 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
- Design Control documents creation 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 and management
- Deliverable acceptance testing
- Intercultural competence in 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
Aufgaben
- Drive implementation of Systems Engineering principles in Design Controls
- Define and manage user and stakeholder needs
- Define and manage product requirements
- Define and manage applicable standards
- Lead system and use-related risk management activities
- Oversee and integrate third-party development activities
- Ensure alignment of Design Control and Quality by Design activities
- Collaborate with cross-functional team members to identify process gaps
- Recommend and implement process improvements
- Standardize methods and ways of working
- Collaborate with cross-functional teams to plan testing activities
- Coordinate testing activities
- Plan sample and laboratory resources
- Serve as dedicated systems engineer for projects
- Independently own key deliverables
- Coordinate stakeholder input for project 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
Lockere Unternehmenskultur
- Diverse work environment
- Open corporate culture
- Great Place to Work recognition
- Commitment to diversity
Mentoring & Coaching
- Intensive onboarding process with mentor
Flexibles Arbeiten
- Flexible work models
- Healthy work-life balance
Gesundheits- & Fitnessangebote
- Corporate health management
- Comprehensive health programs
- Exercise programs
Sonstige Vorteile
- Company social benefits
- International organization
- Commitment to equality
- Commitment to equity
- Commitment to inclusion
Karriere- und Weiterentwicklung
- Wide range of career opportunities
- Attractive development opportunities
- Strong international network
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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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