Process engineer (m/w/d)

AbbVie Deutschland GmbH & Co. KG; Ludwigshafen am Rhein; On-site; EUR 90,000 - 130,000; Full time

Job summary

AbbVie Deutschland GmbH & Co. KG is seeking a Senior Systems Engineer for Aesthetic Filler & Combination Products in Germany.

You will join the Device and Combination Product Development team, contributing to the design and development of innovative aesthetic devices and combination products for clinical and commercial stages. You will lead system architecture, risk management, and design control activities, coordinating inputs from multiple disciplines to ensure patient-centric, compliant

Qualifications

• Bachelor’s degree with 7+ years of relevant experience, or Master’s with 5+ years.
• Proven technical leadership and cross-functional collaboration.
• Experience with medical device development and regulatory expectations.

Responsibilities

• Drive holistic Systems Engineering in Design Controls with focus on architecture and integration.
• Define user and stakeholder needs, use cases, and product requirements.
• Lead risk management activities including planning, reporting, and FMEAs.
• Coordinate testing activities and ensure alignment with Quality by Design.

Skills

Systems Engineering

Risk Management

Design Controls

Stakeholder Needs Definition

Cross-functional Collaboration

Education

Bachelor's degree in Engineering or Science

Master's degree in Engineering or Science

Tools

FMEAs

DHF Architecture

Quality by Design

Job description

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.

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

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 docume...