Manufacturing Engineer

About the role

We are seeking a Manufacturing Engineer to join our medical‑device team on a 12‑month rolling contract. The role focuses on ensuring manufacturing processes are robust, compliant and efficient, supporting product launch and ongoing production.

Key responsibilities

• Develop and approve validation protocols (IQ, OQ, PQ) and process‑characterisation reports.
• Write, review and approve Repeat Action Assessments (RAA) and Acceptance Equipment Lists (AELs).
• Update, review and approve manufacturing instructions (SGOIs) and Manufacturing Execution System (MES) documentation.
• Own DMR remediation activities, including NC/CAPA generation and tracking.
• Ensure all DMR remediation tasks are completed within required timelines.

Required profile

• Minimum 2 years of experience in manufacturing, quality or new product introduction within the medical‑device sector.
• Familiarity with medical‑device documentation such as SOPs, change control and PFMEA.

Required skills

• IQ, OQ, PQ validation protocol development.
• Process characterisation and reporting.
• Repeat Action Assessment (RAA) and Acceptance Equipment List (AEL) preparation.
• Manufacturing Instruction (SGOI) and MES document management.
• DMR remediation, NC/CAPA handling.
• Standard Operating Procedures (SOP) creation and maintenance.
• Change‑control procedures.
• Process Failure Mode Effects Analysis (PFMEA).