Test & Validation Engineer Medical Devices

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

Qualifications :

Must Haves:

• 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

Nice To Haves:

• 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

Additional Information :

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

Remote Work :

No

Employment Type :

Full-time