(Professional) Product Engineer as Product Manager for Injection Systems in the LifeCycle (m/w/d)

At Boehringer Ingelheim we develop groundbreaking therapies that improve the life of humans and animals. As a company founded in 1885 and since then in the family owned company, we take a long-term perspective. With 52,000 employees worldwide, we implement our goals and promote a diverse, community and inclusive corporate culture. We are convinced: With talented and ambitious employees and their passion for innovation, we continually lift the boundaries of the attainable.

The place In the field of Device Technology at the Dortmund site, the ''Product Technology'' group will occupy the position of the '''Scientific Expert (Professional) / Product Engineer as a product manager for injection systems in the LifeCycle (m/w/d)' for 2 years. In this role you are responsible for all life cycle management activities of the medical device component (glass syringes, auto injectors and pens) of combination products. With your expertise, you will provide technical support for injection systems (spindle, auto injector, pen) after transfer from the development to maintain the goals regarding quality, cost and security of supply.

In your new role, you are responsible for the technical-technological support of the device component (spraying, auto injectors and pens) from Combination Products after transfer from development. Technically assess specifications and drawings regarding their suitability and serial suitability and are as SME for Design Engineering, Device Design, acc. ISO 13485, CFR 820 responsible. Thanks to your expertise, you represent device operations in the multi-site device subteams and establish and optimize physical-technical analyses and methods for the device component. In addition, you provide technological support for the production sites in the global pharmaceutical network (external & internal) in the lifecycle at e.g. B the evaluation of changes, deviations and other technological issues. Finally, ensure a consistent manufacturing and testing concept for the device component of combination products.

Additional tasks for the role of Professional Scientific Expert/Product Engineer (m/w/d) They are responsible for the content and release of specifications, drawings, CAD models with regard to their suitability, compliance and serial suitability. They take over the technological support of the interface to the device supplier as well as the creation and maintenance of rationales, SJDs and accompanying documentation. The planning, preparation, evaluation and documentation of experiments and problems (DoEs, Design Verification, Transport Studies), e.g. in the context of Design Changes with influence on design verification and validation documents, is your responsibility. Furthermore, you represent and answer the relevant documents, rationals, specifications to external partners (suppliers) and authorities (TÜV, FDA) e.g. in the audit case. You work with the content when creating the corresponding registration documentation and prepare make-or-buy decisions of devices with special consideration of serial suitability.

Master in Engineering, Mechanical Engineering or Pharmaceutical Engineering First experience and knowledge in the field of medical devices and combination products Ideally experience in the development and production of injection systems Ability to work with international and external partners as well as safe occurrence in the multicultural environment Negotiating skills, ability to present and resilience on the occurrence of suppliers, external partners and government representatives High level of conceptual thinking, target orientation and flexibility, combined with the ability to precisely formulate in word and writing Flowing German and English skills Additional Requirements for the Role as a Professional Scientific Expert/Product Engineer (m/w/d) Multiannual, Hands-on Experience in the Development Steering and Launch of Combination Products, preferably in the Inject Abilia Understanding the rules and guidelines for medical devices, combination products and drug-device combinations as well as accompanying international standards (ISO 13485, CFR820, Design Control, ISO 14971, MDR) Experience in the field of the corresponding test methods (physical technical, metric tests) and knowledge of the relevant production methods (injection casting, assembly, camera technology, metal processing) The recruitment process: 1st step: Online application - Application deadline is 20.05.2025 2nd step: Virtual learning from the beginning of May 3rd step: Interviews on site from the middle/end of May

With us you can grow, work together, be innovative and improve life. We offer you challenging activities in a respectful and collegial global working environment with a variety of innovative thinking and methods. In addition, training and development are of central importance for all employees, because their growth is our growth. Boehringer Ingelheim is a global employer who is committed to equal opportunities and is proud of its diverse and inclusive culture. We welcome the diversity of perspectives and strive for an inclusive environment, from which our employees, patients and communities benefit. You want to know more? Then read https://www.boehringer-ingelheim.com JOBV1_EN