Research And Development Engineer


Weil am Rhein
Permanent
Negotiable
Regulatory
PR/535932_1741126869
Research And Development Engineer

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.

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