Senior Manufacturing Engineer

About the role

The Medical device company in Grecia is looking for a highly motivated Senior Manufacturing Engineer to support the launch and growth of its Costa Rica operations. You will develop, validate, and continuously improve manufacturing processes, equipment, and tooling to ensure safe, efficient, and compliant production of medical devices.

Key responsibilities

• Support new product introductions and product transfers from other manufacturing sites.
• Design and optimise manufacturing layouts, workflows, labour standards, and space utilisation.
• Estimate production times, labour requirements and manufacturing costs.
• Collaborate with Engineering, Quality, Operations and Supply Chain to develop scalable solutions.
• Identify, specify, evaluate and implement manufacturing equipment and tooling with external suppliers.
• Execute and document process validations (IQ, OQ, PQ) and risk assessments such as FMEA.
• Apply SPC and data‑analysis techniques to monitor and improve process performance.
• Monitor key metrics (yield, OEE, scrap, productivity) and implement corrective actions.
• Investigate non‑conforming materials, perform root‑cause analysis and support CAPA.
• Prepare and support Engineering Change Orders and related documentation.
• Train production personnel and lead operators on processes and best practices.
• Develop and maintain technical documentation, work instructions and process specifications.
• Present technical information and project updates to cross‑functional teams and management.

Required profile

• Bachelor’s degree in Mechanical, Electrical, Biomedical, Industrial Engineering or a related technical field.
• Bilingual in English and Spanish.
• Minimum 4 years of engineering experience in the medical device industry.
• Experience with product transfers, start‑up or scale‑up manufacturing environments.
• Hands‑on experience with process validation (IQ, OQ, PQ) and risk management tools such as FMEA.
• Familiarity with regulated environments (FDA, ISO 13485, GMP).

Required skills

• Strong knowledge of manufacturing processes, equipment and tooling.
• Working knowledge of SPC, statistical analysis and process capability studies.
• Lean Manufacturing principles.
• FMEA, IQ, OQ, PQ validation activities.
• Microsoft Office proficiency.