Test & Validation Engineer - Medical Devices

Requirements

• Degree in Mechanical Engineering, Medical Technology or a related field
• Solid work experience in test method development, validation and verification testing of medical devices
• Experience with force and torsion measurement equipment (preferable Zwick, Stable Micro Systems)
• Knowledge in statistical analysis (preferable JMP)
• Knowledge of applicable medical device regulations and standards, such as: ISO 13485, ISO 11608
• Strong quality mindset and familiarity with design control processes and GMP
• Good communication skills and ability to work in cross-functional teams
• Fluent in English, German is an advantage
• Experience with plastics design, especially injection molding
• Hands-on experience with 3D CAD tools (preferably SolidWorks)
• Solid understanding of mechanical design principles and tolerance analysis
• At medmix, you will become part of a renowned team. Attractive compensation and a wide range of additional benefits come as standard. You can expect the following:
• Flexible working hours via our flextime model
• 30 days of vacation per year
• Company pension scheme
• Employee savings plan
• Public transport ticket subsidy
• Pluxee Benefit
• Discounts via the "Corporate Benefits" and "Benefits me" apps
• Regular company events

Benefits

Additional Information

Product Development Support Contribute to the development of new drug delivery devices and the adaptation of existing platforms to customers' drug products Collaborate with cross-functional teams including R&D, Quality, and Manufacturing Test Method Development Develop, implement, and optimize test methods for needle-based injection systems Design, build, and qualify test fixtures, setups, and adapters for components and assemblies Specify and select appropriate test equipment Requirements & Test Design Analyse product requirements, drawings, and specifications Derive and document test cases and acceptance criteria Create detailed and structured test plans based on product specifications and relevant standards Testing & Validation Execute engineering, feasibility, and design verification testing Perform test method validation according to applicable standards and guidelines Support verification and validation (V&V) activities in compliance with design control processes Documentation & Compliance Generate clear and compliant documentation (protocols, reports, validation documentation) Ensure traceability between requirements, test cases, and results Support test method transfer to internal and external manufacturing sites

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