We have a current opportunity for a Research And Development Engineer on a permanent basis. The position will be based in Weil am Rhein. For further information about this position please apply.
R&D Responsibilities
- Participate in process design and verification/validation for related products.
- Prepare operational instructions, technical drawings, and product quality requirements.
- Execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for new equipment.
- Troubleshoot equipment and tooling issues, along with performing basic maintenance as needed.
- Transfer technical documentation, including Device Master Records (DMR) and Design History Files (DHF).
Project Responsibilities
- Serve as the primary contact and manage the entire process of transferring product production knowledge between facilities.
- Collaborate with cross-functional teams to drive projects and ensure adherence to timelines.
- Oversee project planning and progress control to facilitate smooth and successful transitions.
- Supervise the setup of local production lines, ensuring compliance with quality and efficiency standards.
- Ensure readiness of capabilities and proper transfer of project-related knowledge and technology.
Qualifications
- Bachelor's degree or higher in Engineering, Materials Science, Mechanical Engineering, or a related field.
- Minimum of 5 years of experience in the Class III Medical Device industry, with a preference for experience in balloon products.
- Strong project management experience, with Project Management Professional (PMP) certification preferred.
- Demonstrated experience in product manufacturing transfers.
- Proficient in Microsoft Office and CAD software such as SolidWorks or Creo.
- Familiarity with FDA and CE regulatory requirements.
- Proficiency in German and Mandarin, both spoken and written, is essential; English proficiency is a plus.
