Job
- Level
- Senior
- Location
- Ludwigshafen am Rhein
- Working Model
- Onsite
- Job Field
- Application
- Employment Type
- Full Time
- Contract Type
- Permanent employment
Job Summary
In this role, you will develop innovative aesthetic devices and combination products for clinical studies, work on system architectures, manage risks and requirements, and coordinate testing and development activities within a global team.
Your role in the team
- We are looking for a Senior Systems Engineer to join our Device and Combination Product Development team in R&D.
- You will contribute to the development of exciting new aesthetic devices and therapeutic combination products for various phases of clinical studies and work closely with cross-functional colleagues in operations as programs transition to commercial development.
- In this role you're also responsible for integration of inputs and risks from multiple disciplines to ensure robust patient-centric product design and performance.
- In this role, you will be working with a global team of exceptional scientists, engineers, and leaders on a variety of devices, drug delivery systems from syringes to autoinjectors to complex electromechanical pumps, with a focus on Aesthetic Filler devices.
- Your expertise and leadership will ensure these systems are safe and effective in meeting their intended use for clinical and commercial development programs.
- Drive the implementation of holistic Systems Engineering principles within the Design Controls process, with a focus on system architecture and integration, Design Inputs, traceability, risk management, change management, and DHF architecture.
- Define and manage user and stakeholder needs, use cases, product requirements, and applicable standards throughout the product development lifecycle.
- Leitung der system- und nutzungsbezogenen Risikomanagementaktivitäten, einschließlich Risikoplanung und -berichterstattung, Systemrisikobewertungen sowie Design- und Prozess-FMEAs.
- Überwachen und integrieren Sie die Entwicklungsaktivitäten Dritter und stellen Sie die Übereinstimmung von Design Control und Quality by Design-Aktivitäten sicher.
- Collaborate with cross-functional team members to identify process gaps, recommend and implement improvements, and help standardize methods and ways of working to enhance consistency, efficiency, operational effectiveness, and the development of sustainable business and organizational strategies.
- Collaborate with cross-functional teams to plan and coordinate testing activities, including sample and laboratory resource planning, and drive improvements to processes, methods, and ways of working.
- Serve as the dedicated systems engineer for projects, independently owning key deliverables and coordinating stakeholder input as needed to support successful execution.
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Our expectations of you
Education
- Bachelor's degree in Engineering, Science, or a closely related discipline with 7+ years of relevant experience, or a Master's degree with 5+ years of relevant experience.
Qualifications
- Nachweisliche Fähigkeit, technische Leitung zu übernehmen, und Sicherstellung, dass Systemdesign und Dokumentation den geltenden Sicherheits- und Regulierungsanforderungen entsprechen.
- Strong expertise in systems engineering principles including user and stakeholder needs definition; requirements specification; risk management, product architecture, configuration management, traceability, and change management.
- Expertise in DHF management and creating various Design Control documents in compliance with regulations.
- Strong analytical and problem-solving skills, with the ability to resolve key project challenges, make sound decisions, identify risks, and develop appropriate mitigation plans.
- Strong written and verbal communication skills, including scientific writing, combined with a self-driven and structured approach to managing priorities and timelines.
- Excellent written and oral communication skills in English as well as in German with the willingness to travel internationally as required (10-20%).
Experience
- Expertise in product development from initial concept to market release is desired, with direct experience in combination product or medical device development and familiarity with FDA 21 CFR Part 820.30, 21 CFR Part 4, ISO 14971, ISO 13485, and EU MDR preferred.
- Experience working with third-party vendors, including vendor communication, management, and deliverable acceptance testing; intercultural competence in a global environment.
- Experience with Aesthetic Filler products is preferred.
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What we offer
- with a diverse work environment where you can have a real impact
- with an open corporate culture
- with an attractive salary
- with an intensive onboarding process with a mentor at your side
- with flexible work models for a healthy work-life balance
- with a corporate health management that offers comprehensive health and exercise programs
- with company social benefits
- with a wide range of career opportunities in an international organization
- with top-tier, attractive development opportunities
- with a strong international network
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Topics You Will Work On
Job Locations
About Your Employer
AbbVie Deutschland GmbH & Co. KG
AbbVie is a global biopharmaceutical company that was founded in 2013 after separating from Abbott Laboratories. The company's mission is to use its expertise, dedicated staff, and unique approach to innovation to develop and market advanced therapies to treat some of the world's most complex and serious diseases.
Description
- Company Size
- 250+ Employees
- Company Type
- Established Company
- Working Model
- Hybrid, Onsite
- Industry
- Pharmaceutical Sector, Chemical Industry, Biotech, Science, Research
Senior Systems Engineer
- Location
- Ludwigshafen am Rhein
- Working Model
- Onsite
- Diversity
- Open for all genders
