Production Engineer

• Plan, coordinate, and monitor day-to-day production activities to ensure smooth workflow and timely delivery.

• Optimize production processes to achieve maximum efficiency and quality.

• Ensure production output meets required quality standards and ISO 13485 compliance.

• Collaborate with cross-functional teams (Quality, Maintenance, and Supply Chain) to resolve production issues.

• Prepare and maintain production records, reports, and documentation in line with QMS and regulatory requirements.

• Support process validation, equipment qualification, and continuous improvement initiatives.

• Assist in the implementation of Lean Manufacturing and 5S principles on the shop floor.

• Train and supervise operators and technicians in standard work procedures and safety protocols.

• Monitor equipment performance and coordinate preventive maintenance activities.

• Contribute to CAPA actions related to production processes.

Qualifications & Experience:

• Diploma or Bachelor's in Mechanical, Production Engineering, or related field.

• 1–2 years of experience in a production/manufacturing environment, preferably in medical devices or pharmaceutical industry.

• Hands-on experience with ISO 13485 certified systems is mandatory.

• Familiarity with medical device regulations is an advantage.