Process Development Engineer Medical Devices Specialist
vor 3 Wochen
Key Responsibilities:
- Develop and optimize manufacturing processes for existing and novel medical devices, collaborating with product realization teams.
- Conduct process characterizations and validations independently, documenting results.
- Ensure product quality by analyzing quality factors based on statistical parameters.
- Support the implementation of new technologies within the process engineering team.
- Accompany the transfer of new products from development to serial manufacturing between development and operations sites.
Requirements:
- Completed vocational training or engineering degree with professional experience in plastics and process engineering, catheter manufacturing technologies, or plastics processing in serial manufacturing environments.
- Relevant experience in medical technology or a similarly regulated environment is desirable.
- Good understanding of process development, validation, and statistics.
- Experience with product ramp-ups and transfer programs.
- Solid experience in maintaining serial production lines, including root cause analysis and quality investigations.
- 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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