System Engineer - Abram, United States - Skyline Enterprises
Description
Proclinical is seeking a Systems Engineer - Instruments for a client in the medical technology industry. The successful candidate will be involved in projects related to reusable or surgical single-use instruments, ensuring traceability of system requirements throughout the project lifecycle, and contributing to medical risk analysis and safety concept development.
Responsibilities
- Develop system requirements, taking into account clinical application and all other areas with which a device will come into contact during its product lifecycle.
- Collaborate in interdisciplinary project teams responsible for the technical design of instruments.
- Ensure traceability of system requirements throughout the project lifecycle to the final product.
- Contribute to medical risk analysis and safety concept development.
- Support the project team in balancing costs, development time, and technical solutions.
- Work closely with disciplines such as development, product management, production, approval, RSB (reprocessing, sterilization, biocompatibility).
- Communicate and collaborate with external suppliers.
Requirements
- Bachelor's degree in medical technology, precision engineering, mechatronics, mechanical engineering, or a similar technical field.
- First professional experience in the development of endoscopes and instruments.
- Knowledge of disposable products and relevant standards (IEC60601-1, ISO14971) is advantageous.
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