Medical Device Process Development Specialist
vor 2 Wochen
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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