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
FAQs
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