Test & Validation Engineer - Medical Devices at medmix

Stuttgart, Baden-Württemberg, Germany -

Full Time

Start Date

Immediate

Expiry Date

12 Oct, 26

Salary

0.0

Posted On

14 Jul, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Test Method Development, Validation And Verification, Medical Device Regulations, Statistical Analysis, Force And Torsion Measurement, Design Control Processes, GMP, ISO 13485, ISO 11608, SolidWorks, Mechanical Design, Tolerance Analysis, Plastics Design, Injection Molding, 3D CAD, English Fluency

Industry

Medical Device

Description

Company Description medmix is a global leader in high-precision delivery devices. We hold leading positions in the healthcare, consumer, and industrial end markets. Our customers benefit from our commitment to innovation and technological advancement, reflected in over 900 active patents. With 14 production sites worldwide and a highly motivated, experienced team of nearly 2,700 employees, we offer our customers uncompromising quality, proximity, and flexibility. Haselmeier, part of medmix, has been established in the healthcare market for over 100 years. With a workforce of around 240, Haselmeier has been a pioneer in the development of subcutaneous injection pens since the 1960s. We continue to drive innovation in self-injection pens, covering everything from design and manufacturing to packaging and delivery. We have developed solutions in scalable volumes for numerous pharmaceutical partners - always applying state-of-the-art engineering practices - and we aim to evolve further. We develop our products using a patient-centric approach. Our injection devices are used across various therapeutic areas, helping patients with diabetes, supporting fertility treatments, and even offering an option for gentle cancer therapy. Job Description 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 Business Segment: Drug Delivery Location: Stuttgart Alternate Location : Stuttgart

Responsibilities

Develop and optimize test methods and fixtures for needle-based injection systems while collaborating with cross-functional teams. Execute design verification testing and generate compliant documentation to ensure traceability and regulatory adherence.