production engineer, medical devices

Rontis Hellas SA, a Greek multinational healthcare company, active in the field of specialty healthcare (R&D, production, international promotion and distribution of pharmaceuticals & medical devices), is seeking to employ a highly skilled and hands-on:

Production Engineer, Medical Devices 

The Production Engineer is responsible for implementing all necessary actions for the medical devices’ production, ensuring alignment with the standard operating procedures (SOPs), as well as complying with the quality procedures of the department to meet the necessary quality standards, customers’ expectations and regulatory requirements.

Key responsibilities :

• Coordinates the production of medical devices in cooperation with the R&D & Production Director.

• Controls and inspects all the production activities.  Designs, modifies, and improves manufacturing processes (within guidelines) to increase productivity and efficiency.

• Creates and overlooks production plans and schedules to ensure timely and cost-effective output.

• Oversees the production personnel during production activities’ performance. Oversees the quality controls implemented by production personnel as indicated from work instructions.

• Identifies and resolves issues that arise in the production process, including machinery malfunctions and process inefficiencies. Leads the trouble shooting and problem-solving actions. Communicates with the R&D & Production Director for problems/issues occurred during the production.

• Adjusts the production machinery according to manufacturer’s instructions and machinery manual and in internal alignment with the R&D & Production Director.

• Ensures adequate controls are in place for the timely adjustment of equipment and production systems, identifies malfunctions and then either initiates actions for their restoration or cooperates closely with the technical department for their repair.

• Suggests proposals for improvements or for maintenance actions.

• Ensures health and safety measures are respected by production personnel and that all production processes comply with safety regulations and standards.

• Ensures timely training of production personnel on new or improved operating procedures and safety guidelines.

Qualifications / Required skills:

• Degree of Technical Institute, Mechanical Engineering, Electrical Engineering, Electronics, Chemical Technology, Biotechnology or respective science.

• Prior experience in the wider pharmaceutical or medical device field will be considered a plus., specifically in engineering roles. Prior experience in catheters’ production and assembly will be considered a major plus

• Solid knowledge and understanding of ISO standards, GMP, MD regulation and compliance requirements

• Strong problem-solving, investigative, and analytical skills

• Ability to prioritize and handle multiple tasks, projects, and deadlines in a high-compliance environment 

• Excellent communication abilities, in both Greek & English language.