Medical Device Process Development Specialist

vor 2 Wochen


Dresden, Sachsen, Deutschland Heraeus Vollzeit

Key Responsibilities:

  • Develop and optimize manufacturing processes for medical devices, collaborating with cross-functional teams.
  • Conduct process characterizations and validations, documenting results independently.
  • Ensure product quality by analyzing statistical parameters and supporting process improvements throughout the product lifecycle.
  • Support the implementation of new technologies and processes, working closely with the process engineering team.
  • Facilitate the transfer of new products from development to serial manufacturing, collaborating with development and operations sites.

Requirements:

  • Completed vocational training or engineering degree in plastics and process engineering, catheter manufacturing technologies, or plastics processing.
  • Professional experience in medical technology or a similarly regulated environment is desirable.
  • Strong understanding of process development, validation, and statistics.
  • Experience with product ramp-ups and transfer programs, as well as maintaining serial production lines.
  • Excellent communication skills in German and English, both verbally and in writing.
  • Familiarity with standard IT tools and change control systems.


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