Mechanical Engineer as Device Manager (m/f/d)

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 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? You’ve come to the right place!

In our Device Deveopment 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 Senior Mechanical Engineer to join our Combination Product Development team to contribute to the development and launch of exciting new 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 ultimately verification and validation activities that result in robust devices. These devices enable the delivery of AbbVie’s innovative medicines targeted at difficult-to-cure diseases with the goal of making a remarkable impact on people’s lives.

As Senior Mechanical Engineer you would be part of a multi-disciplinary team of professionals working at the intersection of engineering and biopharmaceuticals. The problems you would help to solve relate not only to the function of innovative devices, but also the way in which they interact with drug products and the human body. If you are a self-motivated person who thrives on solving complex problems and are excited by the idea of taking on the toughest health challenges, this opportunity might be for you.

• Drive the mechanical design process, ensuring robust, reliable, and user-friendly products through partnerships.
• Oversee the development of devices for design verification and validation. Work closely with the development partners and manufacturers to ensure design feasibility and reliability.
• Provide technical expertise and mentorship for the organization. Foster a collaborative environment to promote innovation and problem-solving.
• Conduct feasibility assessment of different device solutions, including early prototyping, analysis, and lab testing.
• Execute feasibility and engineering confidence tests to determine design viability and margin.
• Plan the Design Outputs strategy and prepare Design Output deliverables for the DHFs following Design Controls.
• Support assembly process development for integrated combination products.
• Provide support for design verification (test method development, issue resolution).
• Perform root cause analysis and corrective action when required.
• Carry out analytical modeling of key performance attributes.
• Maintain comprehensive documentation of design processes, specifications, and test results. Ensure compliance with quality management systems and regulatory bodies.
• Work with software, electrical, and systems engineering teams, as well as quality assurance and regulatory affairs, to ensure seamless product integration.
• Stay abreast of industry trends, new technologies, and regulatory changes. Implement best practices for mechanical design and development.
• Some travel required.

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.
• Demonstrated expert knowledge and experience in more than one discipline in combination product development within the pharmaceutical space.
• Experience developing a range of mechanical, electromechanical and software-driven medical devices, preferably in the drug delivery space and subcutaneous delivery.
• Detailed understanding of principles and practice of Design Controls (CFR 820.30 / ISO 13485) and Risk Management (ISO 14971).
• GMP, regulatory and CTD knowledge considered an asset.
• Strong communication skills (both written and verbal) with the ability to present complex information clearly to various stakeholders. Capability to influence without direct authority.
• Excellent CAD, mechanical design, analytical and problem-solving skills. Ability to troubleshoot complex mechanical issues. SolidWorks proficiency would be an asset.
• Strong knowledge of DfX principles, material properties, material selection and manufacturing processes.
• Expertise in computational analysis (FEA, system modeling, tolerance analysis) and descriptive statistics.
• Experience with physical prototyping (including 3D printing, machining, etc).
• Experience with a wide range of testing equipment and methods.
• Ability to create and manage schedules for sub-tasks and work streams for which you are responsible.
• A keen eye for identifying project risks and proactively developing mitigation plans.

• 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