Start your mission at Bentley now Become an important part of our international team and work together with us to give people around the world a better quality of life. Support us on our way to a successful future with innovative products for minimally invasive treatment of vascular diseases. We promise a diverse work environment with good career opportunities with an exceptional employer
For our location in Frauenfeld (Switzerland), we are looking for a motivated colleague (m/f/d) to start as soon as possible in a full-time on-site position as:
Your mission
* 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.
Your profile
* 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.
Why us?
Our agile and appreciative corporate culture with flat hierarchies and short decision-making processes is what characterizes our dynamic and efficient way of working. All areas of responsibility operate independently, shaped by our start-up mentality combined with the structure and power of an established company. Flexible working hours, regular team events, training, and further education opportunities allow you to advance your development according to your individual needs.
*Are you ready for Bentley? #yourmissionstartsnow*
If you have any questions, please contact Kristina Steidler at
Online application