At Bentley, you will embark on a mission to contribute to our international team and collaborate with us to improve the quality of life for people worldwide. We are committed to developing innovative products for minimally invasive vascular disease treatment.
Your Mission
* You will support product and process transfers to production by integrating new technologies, materials, and process steps while ensuring compliance with external standards, internal rules, and project requirements.
* You will support product design verification and process validation (OQ & PQ) activities, aligning them with both design and production processes.
* You will evaluate the feasibility of optimizing existing process steps or implementing new ones to reduce scrap without impacting manufacturing flow.
* You will stay up-to-date on production machinery advancements and investigate their potential implementation considering return on investment.
* You will provide support in generating Process FMEAs and update them to address emerging risks.
* You will develop and evaluate test methods to test product requirements, analyze data using statistical techniques, and communicate results to a cross-functional team.
* You will comply with relevant regulatory requirements and associated quality systems and business policies.
* You will receive broad technical and administrative direction from Head of Engineering but have full responsibility for formulating and executing engineering tasks.
* You will actively participate in engineering team tasks and understand engineering goals and timelines.
* You will be capable of performing preliminary prototyping to support manufacturing feasibility studies.
* You will support root cause analysis and corrective/preventive actions for non-conforming product or process deviations.
* You will collaborate with the Quality Department and manufacturing floor to establish standards and reliability objectives for finished products.
Requirements
* Bachelor's degree in Biomedical, Mechanical, or Material Engineering; Master's degree is an advantage.
* At least five years of professional experience with balloon catheters.
* Demonstrated ability to develop a 'hands-on' approach, requiring personal initiative and responsibility while operating at a high level of performance and efficiency.
* Proficient in technical writing and speaking in English; German is a plus.
* Knowledge in relevant standards (ISO 13485, 10555, etc.).
* Experience in reading and writing technical documentation.
* Hands-on experience with Solidworks in creating 3D models and technical drawings.
* Good knowledge of medical device materials and technologies used in peripheral and/or coronary vascular applications.
* Experience with vascular stents is an advantage.
* Strong team player with very high organizational, interpersonal, communication, and intercultural skills.
* Creative and systematic person with an entrepreneurial mindset.
* Outstanding problem-solving and design skills.
* Excellent ability to work in interdepartmental groups and with other critical functions to form a cohesive project team.
Why Us?
In this role, you will primarily focus on designing and developing manufacturing processes related to existing and new products. You will implement new process steps, enforce process optimizations, evaluate and prepare new machinery for full utilization in production, and support qualification activities of new machines and process parameters.
You will improve testing procedures in line with required standards and regulations, compile relevant protocols and reports, and directly support production in any problems that may arise.
Bentley Switzerland AG promotes an agile and open working culture. You may also be assigned tasks outside the mentioned department, provided you can contribute your knowledge and expertise in a mutually beneficial way.