Profile
We are seeking a highly skilled individual with a Bachelor's degree in Biomedical, Mechanical, or Material Engineering. A Master's degree is an advantage and will be considered favorably. Ideal candidates will have at least five years of professional experience specifically working with balloon catheters.
The successful applicant should demonstrate a proactive, “hands-on” approach, showcasing personal initiative and responsibility while operating with high levels of performance and efficiency. Proficiency in technical writing and fluency in English is essential; knowledge of German would be a plus.
The ideal candidate should possess:
- Knowledge of relevant standards (ISO 13485, 10555, etc.)
- Experience in reading and writing technical documentation
- Hands-on expertise with SolidWorks for creating 3D models and technical drawings
- Good knowledge of medical device materials and technologies applicable to peripheral and/or coronary vascular applications
- Experience with vascular stents, which is advantageous
- Strong teamwork abilities combined with excellent organizational, interpersonal, communication, and intercultural skills
- A creative and systematic mindset with entrepreneurial thinking
- Outstanding problem-solving and design capabilities
- Excellent ability to collaborate within interdepartmental groups to form a cohesive project team
Job Responsibilities
The selected candidate will be responsible for supporting product and process transfers to production by integrating new technologies, materials, and process steps, all while ensuring compliance with applicable standards, internal regulations, and project requirements. Key responsibilities include:
- Supporting product design verification and process validation (OQ & PQ) activities while ensuring alignment with both design and production processes.
- Evaluating the feasibility of optimizing existing process steps and implementing new ones to minimize scrap without disrupting manufacturing flow.
- Keeping track of state-of-the-art production machinery and investigating the potential for their implementation, considering the Return on Investment.
- Providing support in generating Process FMEAs and updating them to address emerging risks.
- Developing and assessing test methods to evaluate product requirements, analyzing data using statistical techniques, and communicating results to cross-functional teams.
- Ensuring compliance with regulatory requirements (i.e., MDR, GMP, ISO, FDA, etc.) and associated quality systems and business policies.
- Receiving technical and administrative direction from the Head of Engineering while taking full responsibility for formulating and executing engineering tasks.
- Actively participating in the engineering team's tasks and understanding engineering goals and timelines.
- Performing preliminary prototyping to support manufacturing feasibility studies.
- Supporting root cause analysis and corrective/preventive actions (CAPA) for non-conforming products or process deviations.
- Collaborating with the Quality Department and the manufacturing floor to establish standards and reliability objectives for finished products.
- Completing all other tasks assigned by management and/or superiors.
Interested candidates are encouraged to apply online using the form below. Please note that only applications matching the job profile will be considered.