Senior Device Mechanical Engineer (all genders)12.06.2025 AbbVie Deutschland GmbH & Co. KG Ludwigshafen am Rhein
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Senior Device Mechanical Engineer (all genders)
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Ludwigshafen am Rhein
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Senior Device Mechanical Engineer (all genders)
Ludwigshafen am Rhein
Aktualität: 12.06.2025
Anzeigeninhalt:
12.06.2025, AbbVie Deutschland GmbH & Co. KG
Ludwigshafen am Rhein
Senior Device Mechanical Engineer (all genders)
Aufgaben:
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.
Qualifikationen:
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.
Berufsfeld
Bundesland
Standorte
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