Job
- Level
- Senior
- Ort
- Ludwigshafen am Rhein
- Arbeitsmodell
- Onsite
- Job Feld
- Application
- Anstellung
- Vollzeit
- Vertragsart
- Unbefristetes Dienstverhältnis
Job Zusammenfassung
In dieser Position entwickelst du innovative ästhetische Geräte und Kombinationen für klinische Studien, arbeitest an Systemarchitekturen, Risiken und Anforderungen, und koordinierst Testing- und Entwicklungsaktivitäten im internationalen Team.
Deine Rolle im 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.
- 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 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.
Unsere Erwartungen an dich
Ausbildung
- 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.
Qualifikationen
- Proven ability to provide technical leadership, ensuring system design and documentation comply with applicable safety and regulatory requirements.
- Strong Expertise in Systems Engineering principles including user and stakeholder need definition; requirements definition; 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 Englisch as well as in German with the willingness to travel internationally as required (10-20%).
Erfahrung
- Expertise in product development from initial concept to release to market 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, ISO14971, 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.
Unser Angebot
- 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
Themen mit denen du dich im Job beschäftigst
Job Standorte
Das ist dein Arbeitgeber
AbbVie Deutschland GmbH & Co. KG
AbbVie ist ein weltweit führender Anbieter von biopharmazeutischen Produkten, der 2013 durch die Trennung von Abbott Laboratories entstanden ist. Unser Ziel ist es, unsere Expertise, unsere people-first-Strategie und unser innovatives Denken zur Entwicklung und zum Vertrieb besonderer Therapien zu nutzen, mit denen wir some of the world's most complex and serious diseases bekämpfen können.
Description
- Unternehmensgröße
- 250+ Employees
- Unternehmenstyp
- Etablierte Firma
- Arbeitsmodell
- Hybrid, Onsite
- Branche
- Pharma, Chemie, Biotech, Wissenschaft, Forschung
Senior Systems Engineer
- Ort
- Ludwigshafen am Rhein
- Arbeitsmodell
- Onsite
- Diversität
- Für alle Personen geeignet (m/w/d)
