System Engineer - Abram, United States - Skyline Enterprises

Skyline Enterprises

Verified Company

Abram, United States

3 weeks ago

Posted by:

Meredith Sinclair

beBee Recruiter

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.