Senior Design Engineer(m/w/x)

Beschreibung

In this role, you will be at the forefront of developing innovative drug delivery devices, guiding projects from initial concept to market launch while ensuring high-quality standards and compliance throughout the process.

Anforderungen

• •Degree in mechanical engineering or equivalent
• •Preferably 3 years of experience in medical device development
• •Proficient spoken communication and excellent technical writing skills in English
• •Experience in designing plastic and metal components, tolerance analysis, metrology, lab testing
• •Experience in material qualification
• •Good knowledge in design for manufacturing and assembly
• •Good knowledge in key regulations and standards (e.g. ISO23098, ISO 11608, ISO 10993, MDR, Design Controls)
• •Design History File documentation
• •Ability to interact with cross functional team in matrix organization

Aufgaben

• •Develop platform for drug device combination products
• •Participate in cross-functional project activities
• •Engage in the complete development process of medical devices
• •Create and review intellectual property
• •Manage and maintain CAD, 3D models, and drawings
• •Conduct and maintain tolerance analysis
• •Size and specify plastic and metallic components
• •Collaborate with third-party suppliers and tool makers
• •Manage testing and characterization for compliance and performance
• •Perform root cause analysis and develop solutions
• •Ensure components meet quality standards for clinical trials
• •Write design history file documents and specifications