About this role
About AbbVie AbbVie’s mission is to discover and deliver innovativemedicines that solve serious health issues today and address themedical challenges of tomorrow. We strive to have a remarkable impacton people’s lives across several key therapeutic areas: immunology,oncology, neuroscience, eye care, virology, women’s health andgastroenterology, in addition to products and services across itsAllergan Aesthetics portfolio. For more information about AbbVie,please visit us at www.abbvie.com . Job Description People. Passion.Possibilities. Three words that make a world of difference. More thana job. It's a chance to make a real difference. Welcome to AbbVie! Aspart of an international company with 57,000 employees worldwide andaround 3,500 employees in Germany, you will have the opportunity ofaddressing some of tomorrows unmet medical needs in closecollaboration with your colleagues. Are you passionate about improvingglobal health care? Do you want to contribute to improving patients'quality of life through your expertise? In a challenging workenvironment that offers opportunities of developing and increasingyour own skills? Youve come to the right place! Together, we breakthrough – as Senior Systems Engineer – Aesthetic Filler &Combination Products (all genders) We are looking for a Senior SystemsEngineer to join our Device and Combination Product Development teamin R&D. You will contribute to the development of exciting newaesthetic devices and therapeutic combination products for variousphases of clinical studies and work closely with cross-functionalcolleagues in operations as programs transition to commercialdevelopment. In this role you’re also responsible for integration ofinputs and risks from multiple disciplines to ensure robustpatient-centric product design and performance. In this role, you willbe working with a global team of exceptional scientists, engineers,and leaders on a variety of devices, drug delivery systems fromsyringes to autoinjectors to complex electromechanical pumps, with afocus on Aesthetic Filler devices. Your expertise and leadership willensure these systems are safe and effective in meeting their intendeduse for clinical and commercial development programs. Make your markDrive the implementation of holistic Systems Engineering principleswithin the Design Controls process, with a focus on systemarchitecture and integration, Design Inputs, traceability, riskmanagement, change management, and DHF architecture. Define and manageuser and stakeholder needs, use cases, product requirements, andapplicable standards throughout the product development lifecycle.Lead system and use-related risk management activities, including riskplanning and reporting, system risk assessments, and design andprocess FMEAs. Oversee and integrate third-party developmentactivities and ensure alignment of Design Control and Quality byDesign activities. Collaborate with cross-functional team members toidentify process gaps, recommend and implement improvements, and helpstandardize methods and ways of working to enhance consistency,efficiency, operational effectiveness, and the development ofsustainable business and organizational strategies. Collaborate withcross-functional teams to plan and coordinate testing activities,including sample and laboratory resource planning, and driveimprovements to processes, methods, and ways of working. Serve as thededicated systems engineer for projects, independently owning keydeliverables and coordinating stakeholder input as needed to supportsuccessful execution. Qualifications This is how you make adifference: Bachelor’s degree in Engineering, Science, or a closelyrelated discipline with 7+ years of relevant experience, or aMaster’s degree with 5+ years of relevant experience. Proven abilityto provide technical leadership, ensuring system design anddocumentation comply with applicable safety and regulatoryrequirements. Expertise in product development from initial concept torelease to market is desired with direct experience in combinationproduct or medical device development and familiarity with FDA 21 CFRPart 820.30, 21 CFR Part 4, ISO14971, ISO 13485 and EU MDR preferred.Strong Expertise in Systems Engineering principles including user andstakeholder need definition; requirements definition; risk management,product architecture, configuration management, traceability, andchange management Expertise in DHF management and creating variousDesign Control documents in compliance with regulations. Stronganalytical and problem-solving skills, with the ability to resolve keyproject challenges, make sound decisions, identify risks, and developappropriate mitigation plans. Experience working with third-partyvendors, including vendor communication, management, and deliverableacceptance testing; intercultural competence in a global environment.Experience with Aesthetic Filler products is preferred. Strong writtenand verbal communication skills, including scientific writing,combined with a self-driven and structured approach to managingpriorities and timelines. Excellent written and oral communicationskills in Englisch as well as in German with the willingness to travelinternationally as required (10–20%). What we offer you: with adiverse work environment where you can have a real impact with an opencorporate culture with an attractive salary with an intensiveonboarding process with a mentor at your side with flexible workmodels for a healthy work-life balance with a corporate healthmanagement that offers comprehensive health and exercise programs withcompany social benefits with a wide range of career opportunities inan international organization with top-tier, attractive developmentopportunities with a strong international network At multiple times,we have been globally recognized as a "Great Place to Work" and we areproud to provide our employees with the f