Senior Manufacturing Engineer

Overview

We are seeking an experienced Senior Manufacturing Engineer to join a leading medical device manufacturing organisation. The successful candidate will play a key role in driving manufacturing excellence, supporting process improvements, managing engineering changes, and collaborating across multiple sites to ensure operational efficiency, compliance, and product quality.

This position is ideal for a proactive engineer with a strong manufacturing background, excellent quality-focused problem-solving skills, and experience working within a regulated environment.

Key Responsibilities

• Lead and support manufacturing engineering activities to optimise production processes, improve efficiencies, and reduce waste.
• Drive continuous improvement initiatives using Lean Manufacturing and data-driven methodologies.
• Collaborate with cross-functional teams including Quality, Operations, Supply Chain, R&D, and Regulatory Affairs.
• Work closely with stakeholders across multiple sites to ensure alignment of manufacturing strategies and engineering projects.
• Manage and support engineering change activities through established Change Control processes.
• Conduct root cause investigations and implement effective corrective and preventive actions (CAPA).
• Support process validations, equipment qualifications, and manufacturing transfers where required.
• Ensure all manufacturing activities comply with GMP, regulatory, and quality system requirements.
• Develop and maintain manufacturing documentation, work instructions, and process specifications.
• Provide technical support for production issues and drive sustainable solutions.

Required Experience & Qualifications

• Bachelor's Degree in Engineering or a related technical discipline.
• 3-5+ years' experience as a Manufacturing Engineer, preferably within the Medical Device, Pharmaceutical, or other highly regulated manufacturing sectors.
• Strong understanding of manufacturing processes and engineering principles.
• Experience working within Quality Systems and applying quality engineering methodologies.
• Proven experience managing and supporting Change Management / Change Control processes.
• Experience collaborating effectively with teams across multiple manufacturing sites.
• Strong problem-solving, analytical, and communication skills.
• Ability to manage multiple projects and priorities in a fast-paced environment.

Desirable Experience

• Previous experience working within a warehouse, distribution centre, or logistics environment.
• Knowledge of Lean Manufacturing, Six Sigma, or continuous improvement methodologies.
• Experience supporting process validations (IQ/OQ/PQ).
• Familiarity with ERP systems and manufacturing performance metrics.

Key Competencies

• Cross-functional collaboration
• Stakeholder management
• Change management
• Continuous improvement
• Root cause analysis
• Quality-focused decision making
• Project management
• Technical problem solving