Senior Systems Engineer – Aesthetic Filler & Combination Products (all genders)

• Drive the implementation of holistic Systems Engineering principles within the Design Controls process (system architecture and integration, Design Inputs, traceability, risk management, change management, DHF architecture).
• Define and manage user and stakeholder needs, use cases, product requirements, and applicable standards throughout the product development lifecycle.
• Lead system and use-related risk management activities, including risk planning and reporting, system risk assessments, and design and process FMEAs.
• Oversee and integrate third-party development activities and ensure alignment of Design Control and Quality by Design activities.
• Collaborate with cross-functional team members to identify process gaps, recommend and implement improvements, and help standardize methods and ways of working.
• Plan and coordinate testing activities with cross-functional teams, including sample and laboratory resource planning, and drive process/method improvements.
• Serve as the dedicated systems engineer for projects, independently owning key deliverables and coordinating stakeholder input to support successful execution.
• Contribute to development of aesthetic devices and therapeutic combination products for clinical studies and transition to commercial development.

• Bachelor’s degree in Engineering, Science, or closely related discipline with 7+ years relevant experience, or Master’s degree with 5+ years relevant experience.
• Proven ability to provide technical leadership and ensure system design and documentation comply with safety and regulatory requirements.
• Direct experience in combination product or medical device development preferred; familiarity with FDA 21 CFR Part 820.30, 21 CFR Part 4, ISO14971, ISO 13485 and EU MDR preferred.
• Strong expertise in Systems Engineering principles: user/stakeholder need definition, requirements definition, risk management, product architecture, configuration management, traceability, change management.
• Expertise in DHF management and creating Design Control documents in compliance with regulations.
• Strong analytical and problem-solving skills; ability to identify risks and develop mitigation plans.
• Experience working with third-party vendors, vendor communication, management, and deliverable acceptance testing; intercultural competence in a global environment.
• Experience with Aesthetic Filler products is preferred.
• Excellent written and oral communication skills in English and German.
• Willingness to travel internationally as required (10–20%).

• Diverse work environment with real impact
• Open corporate culture
• Attractive salary
• Intensive onboarding process with a mentor
• Flexible work models for a healthy work-life balance
• Corporate health management with comprehensive health and exercise programs
• Company social benefits
• Wide range of career opportunities in an international organization
• Top-tier development opportunities
• Strong international network
• Employer committed to equality, equity, diversity and inclusion (EED&I)

AbbVies Mission ist es innovative Medikamente zu entdecken, die im Heute schwerwiegende Gesundheitsprobleme lösen und die medizinischen Herausforderungen von morgen angehen. Wir streben danach, in verschiedensten therapeutischen Schlüsselbereichen einen bemerkenswerten Einfluss auf das Leben der Menschen auszuüben: Immunologie, Onkologie, Neurowissenschaften, Augenheilkunde, Virologie, Frauengesundheit und Gastroenterologie sowie Produkte und Dienstleistungen aus dem gesamten Portfolio von AbbVie im Bereich der Allergan Ästhetik.

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Manager Corporate Government Affairs (all genders)

REF: 2211399