AbbVie Deutschland GmbH & Co. KG
Germany, Ludwigshafen am Rhein
About AbbVie AbbVie’s mission is to discover and deliver innovative
medicines that solve serious health issues today and address the
medical challenges of tomorrow. We strive to have a remarkable impact
on people’s lives across several key therapeutic areas: immunology,
oncology, neuroscience, eye care, virology, women’s health and
gastroenterology, in addition to products and services across its
Allergan 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 than
a job. It's a chance to make a real difference. Welcome to AbbVie! As
part of an international company with 57,000 employees worldwide and
around 3,500 employees in Germany, you will have the opportunity of
addressing some of tomorrows unmet medical needs in close
collaboration with your colleagues. Are you passionate about improving
global health care? Do you want to contribute to improving patients'
quality of life through your expertise? In a challenging work
environment that offers opportunities of developing and increasing
your own skills? Youve come to the right place! Together, we break
through – as Senior Systems Engineer – Aesthetic Filler &
Combination Products (all genders) 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. Make your mark
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. Qualifications This is how you make a
difference: 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. Proven ability
to provide technical leadership, ensuring system design and
documentation comply with applicable safety and regulatory
requirements. 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.
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. 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. 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%). What we offer you: 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 At multiple times,
we have been globally recognized as a "Great Place to Work" and we are
proud to provide our employees with the f