We are seeking a high-calibre Senior Manufacturing Engineer to drive high-impact automation, efficiency, and cost-savings projects within our Value Capture Program. Operating in a regulated, world-class manufacturing environment, you will leverage lean methodologies and project management best practices to identify, design, and execute initiatives that optimize resource utilization (Scrap, Consumables, and Direct Labour).
This is a hands-on role requiring strong technical leadership, cross-functional collaboration, and the ability to influence senior stakeholders.
Key Responsibilities
- Project Leadership & Value Capture: Identify, scope, design, and lead end-to-end engineering projects aimed at improving capacity, validation, and cost-savings across our core product range.
- Process Optimization & Lean: Apply Lean and engineering problem-solving principles to eliminate waste, stabilize machine inputs/outputs, and optimize direct labor and material usage.
- Validation Execution: Conduct and oversee Equipment Validation activities, including IQ, OQ, and PQ, ensuring all machinery and assets meet rigorous standards.
- Cross-Functional Collaboration: Partner with Quality, Operations, CSV, and EHS to ensure full compliance with design controls, risk management protocols, and safety standards.
- Stakeholder Management: Secure project funding and alignment from Senior Leadership; deliver weekly status presentations and manage project escalations effectively.
- Compliance: Maintain strict adherence to GMP, ISO, and regulatory system requirements throughout all project lifecycles.
Candidate Profile
Essential Criteria:
- Education: MSc in Engineering or a relevant Scientific discipline.
- Experience: 7+ years in a medium-to-high volume regulated manufacturing environment (e.g., Medical Devices/Orthopaedics, Pharma, Oil & Gas, or Food Processing).
- Regulatory Exposure: Minimum of 2 years of experience working within highly regulated frameworks (FDA/ISO).
- Work Style: A proactive, collaborative approach with a desire to work hands-on from the office alongside fellow engineers on trials and experiments.
Desirable Criteria:
- Deep expertise in FDA and European regulations (21 CFR 820, CFR 11) and medical device validation standards.
- Six Sigma / Lean Black Belt certification with a strong grip on advanced statistics, MSA, SPC, and DOEs.
- Proven technical problem-solving capabilities (A3, Systems Engineering, or Six Sigma methodologies).
- Exceptional communication and presentation skills, with a track record of influencing senior management.
