Senior Manufacturing Engineer

About the role

We are looking for an experienced Senior Manufacturing Engineer to join a leading medical device manufacturing organization. The role focuses on driving manufacturing excellence, supporting process improvements, and ensuring compliance across multiple sites.

Key responsibilities

• Lead manufacturing engineering activities to optimise production, improve efficiency and reduce waste.
• Drive continuous‑improvement initiatives using Lean Manufacturing and data‑driven methods.
• Collaborate with Quality, Operations, Supply Chain, R&D and Regulatory Affairs teams.
• Coordinate engineering change activities through established Change Control processes.
• Conduct root‑cause investigations and implement corrective and preventive actions (CAPA).
• Support process validations, equipment qualifications and manufacturing transfers.
• Maintain GMP, regulatory and quality‑system compliance for all manufacturing activities.
• Develop and update work instructions, process specifications and other manufacturing documentation.

Required profile

• Bachelor’s degree in Engineering or a related technical discipline.
• 3‑5+ years of experience as a Manufacturing Engineer, preferably in medical device, pharmaceutical or other highly regulated sectors.
• Strong understanding of manufacturing processes, engineering principles and quality‑system requirements.
• Proven experience managing Change Management/Change Control processes.
• Excellent problem‑solving, analytical and communication skills.
• Ability to manage multiple projects in a fast‑paced environment.

Required skills

• Lean Manufacturing
• Six Sigma
• Change Control processes
• Root‑cause analysis
• CAPA implementation
• Process validation (IQ/OQ/PQ)
• GMP compliance
• ERP systems
• Manufacturing performance metrics