Senior Development Engineer (m/f/d)

You will support the transfer of products and processes into production by integrating new technologies, materials, and process steps in compliance with external standards, internal regulations, and project requirements.

You will support product design review and process validation (OQ & PQ) activities and ensure compliance with design and production processes.

You will evaluate the feasibility of optimizing existing process steps and/or implementing new steps to reduce waste without impacting the manufacturing process.

You will keep track of the state of the art in production machinery and assess the potential for its implementation.

You will assist in the creation of process FMEA and update it to minimize emerging risks.

You will develop and evaluate test methods for checking product requirements.

You will analyze the data using statistical methods and communicate the results to a cross-functional team.

You will comply with the relevant legal requirements (e.g., MDR, GMP, ISO, FDA, etc.) and the associated quality systems and company guidelines.

You are able to create preliminary prototypes to support feasibility studies for manufacturing.

You support root cause analysis and corrective and preventive actions (CAPA) for non-compliant products or process deviations.

You have a master's degree in biomedical engineering, mechanical engineering, or materials engineering.

You have several years of professional experience, preferably with balloon catheters. Experience with vascular stents is an advantage.

You have knowledge of the relevant standards (ISO 13485, 10555, etc.) as well as the materials and technologies used in medical devices for peripheral and/or coronary vascular applications.

You have experience in writing technical documentation and creating 3D models and technical drawings with Solidworks.

You have strong teamwork skills and are comfortable collaborating across departments.