Role Overview

We are looking for a hands-on Engineer to contribute to the design and development of new diagnostic products, assess technical and regulatory risks, and help set up and validate our pilot-scale production line. This role is ideal for someone who thrives in dynamic environments, enjoys problem-solving, and is eager to grow with the company.

Responsibilities

• Participate in the design, development, and optimization of new in vitro diagnostic products.
• Contribute to risk evaluation, verification, and validation activities.
• Support the setup, qualification, and continuous improvement of the pilot-scale production line, including infrastructure and equipment management.
• Ensure compliance with relevant standards and regulations, including ISO 13485 and IVDR.
• Document processes, designs, and results following internal quality procedures.
• Collaborate closely with a small, highly motivated, and international team.