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

About the Position

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

AbbVie Deutschland GmbH & Co. KG

Ludwigshafen am Rhein

Are you ready to make a significant impact in the development of aesthetic devices and therapeutic combination products? AbbVie Deutschland GmbH & Co. KG is seeking a Senior Systems Engineer to join our Device and Combination Product Development team in R&D. Collaborate with a global team of exceptional scientists, engineers, and leaders to ensure the safety and effectiveness of our products.

Responsibilities

• Drive the implementation of holistic Systems Engineering principles within the Design Controls process.
• 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.
• 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.

Requirements

• 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 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 English as well as in German with the willingness to travel internationally as required (10-20%).

We Offer

• Opportunity to work with a global team of exceptional scientists, engineers, and leaders.
• Competitive salary and benefits package.
• Professional development opportunities.
• Chance to contribute to the development of safe and effective aesthetic devices and therapeutic combination products.

About the Company

AbbVie Deutschland GmbH & Co. KG is a leading global biopharmaceutical company that uses science and technology to create innovative medicines and solutions that address unmet medical needs. Our mission is to improve the quality of life for people by discovering, developing, and delivering breakthrough therapies.

Apply now to join our team and make a significant impact in the development of aesthetic devices and therapeutic combination products.