Senior Device Mechanical Engineer (all genders) (fulltime) (permanent)

AbbVie Deutschland GmbH & Co. KG; Ludwigshafen am Rhein; Vor Ort; EUR 70.000 - 95.000; Vollzeit

Zusammenfassung

AbbVie is seeking a Senior Device Mechanical Engineer to join their Combination Product Development team in Ludwigshafen. You will be instrumental in the design and validation of innovative drug/device combination products that impact patient care. The role requires robust technical expertise, collaborative problem-solving, and a passion for improving health outcomes.

Qualifikationen

• 10+ years of experience with M.Sc. or 6+ years with PhD.
• Experience with drug delivery systems preferred.
• Knowledge of CFR 820.30 / ISO 13485 and ISO 14971.

Aufgaben

• Drive mechanical design for user-friendly products.
• Oversee device verification and validation.
• Conduct engineering confidence tests and maintain compliance documentation.

Kenntnisse

Mechanical Engineering

Problem-solving

Communication

SolidWorks

Design Controls

Risk Management

Prototyping

Analytical Modeling

Analytical Troubleshooting

Ausbildung

M.Sc. in Mechanical Engineering

PhD in Mechanical Engineering

Tools

CAD Software

FEA Software

Jobbeschreibung

AbbVie's mission is to discover and deliver innovative medicines and solutions 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, and eye care – and products and services in our Allergan Aesthetics portfolio.

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 50,000 employees worldwide and around 3,000 employees in Germany, you will have the opportunity of addressing some of tomorrow's 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 to develop and increase your skills? You've come to the right place!

In our Device Development department within R&D at the Ludwigshafen site, you will be working in a team of talented people and experienced management experts.

Together, we break through – as

Senior Device Mechanical Engineer (all genders) (fulltime) (permanent)

REF: R00129313

We are looking for a Senior Mechanical Engineer to join our Combination Product Development team to contribute to the development and launch of innovative drug/device combination products.

Within Combination Product Development, the Product Engineering group is responsible for developing products informed by user needs and product requirements, completing device design & specifications, and conducting verification and validation activities to ensure robust devices. These devices enable the delivery of AbbVie's medicines for difficult-to-cure diseases, aiming to make a significant impact on patients' lives.

As a Senior Mechanical Engineer, you will be part of a multidisciplinary team working at the intersection of engineering and biopharmaceuticals. You will help solve problems related to device function and interaction with drug products and the human body. If you are self-motivated, thrive on solving complex problems, and are excited by health challenges, this role is for you.

• Drive the mechanical design process to ensure robust, reliable, and user-friendly products through partnerships.
• Oversee device development for verification and validation, working closely with partners and manufacturers.
• Provide technical expertise and mentorship, fostering innovation and collaboration.
• Assess feasibility of device solutions, including prototyping, analysis, and testing.
• Conduct feasibility and engineering confidence tests to determine design viability.
• Plan Design Outputs strategy and prepare Design Output deliverables following Design Controls.
• Support assembly process development for integrated products.
• Perform root cause analysis and corrective actions as needed.
• Carry out analytical modeling of key performance attributes.
• Maintain documentation of design processes, specifications, and test results, ensuring compliance with quality standards.
• Collaborate with software, electrical, and systems teams, as well as QA and regulatory affairs, for seamless product integration.
• Stay updated on industry trends, technologies, and regulations, implementing best practices.

This is how you can make a difference :

• M.Sc. in Mechanical Engineering with 10+ years of experience or PhD with 6+ years of experience.
• Expertise in multiple disciplines within combination product development in the pharmaceutical space.
• Experience developing mechanical, electromechanical, and software-driven medical devices, preferably in drug delivery and subcutaneous delivery.
• Knowledge of Design Controls (CFR 820.30 / ISO 13485) and Risk Management (ISO 14971).
• GMP, regulatory, and CTD knowledge is an asset.
• Strong communication skills and ability to influence stakeholders.
• Excellent CAD skills, problem-solving, and troubleshooting abilities; SolidWorks proficiency is a plus.
• Knowledge of DfX principles, materials, and manufacturing processes.
• Experience with computational analysis (FEA, system modeling) and testing equipment.
• Ability to manage schedules and identify project risks proactively.