Manufacturing Engineer – Medical Devices

About the role

The Manufacturing Engineer will develop, implement, validate, and continuously improve manufacturing processes and equipment for medical device production. This role provides technical support, leads improvement initiatives, and ensures compliance with quality, regulatory, and safety standards.

Key responsibilities

• Support daily manufacturing operations by troubleshooting process and equipment issues.
• Develop, optimize, and validate manufacturing processes and production equipment.
• Lead Lean and Six Sigma initiatives to reduce cost and increase productivity.
• Execute IQ/OQ/PQ validations and support equipment qualifications.
• Analyze manufacturing data, identify trends, and implement corrective actions.
• Maintain manufacturing documentation, procedures, and engineering reports.
• Support new product introductions, process transfers, and capacity expansion projects.
• Participate in root cause investigations, CAPA activities, and quality improvement efforts.

Required profile

• Bachelor’s degree in an engineering discipline (Industrial, Mechanical, Electrical/Electronic, etc.).
• 3+ years of manufacturing engineering experience in the medical device industry.
• Advanced English communication and technical writing skills.
• Experience in highly regulated environments (GMP, FDA, ISO 13485).
• Proven project leadership and problem‑solving abilities.

Required skills

• Lean Manufacturing and Six Sigma methodologies.
• Process validation (IQ/OQ/PQ) and equipment qualification.
• Microsoft Office Suite, Minitab, data analysis tools.
• Project management tools.
• Knowledge of GMP, FDA, ISO 13485 regulations.