Senior Manufacturing Engineer – Orthopedic Production

About the role

We are seeking a Senior Manufacturing Engineer to lead end‑to‑end engineering projects for our orthopaedic product range in Ringaskiddy, Cork. The role combines office‑based planning with hands‑on development of trials, experiments, and process improvements.

Key responsibilities

• Represent the Engineering function on quality, cost‑saving, capacity, and validation projects across the orthopaedic portfolio.
• Prepare project documentation covering scoping, design, implementation, and execution.
• Identify and drive savings linked to direct labour inefficiencies, scrap, and consumables spend.
• Align new or modified manufacturing processes with operational, quality, EHS, validation, finance, automation, and maintenance requirements.
• Present weekly status updates and funding needs to senior management.
• Determine machine input/output ranges and conduct IQ, OQ, and PQ activities.
• Partner with Quality, Operations, CSV, and other cross‑functional teams to apply design controls, risk management, and corrective actions.
• Ensure compliance with GMP, ISO, and all health, safety, and environmental standards.

Required profile

• MSc in Engineering or Science with at least 7 years of experience in medium to high‑volume manufacturing (food processing, paint, oil & gas, orthopaedics).
• Minimum 2 years in a regulated environment (FDA/ISO) within the medical‑device sector.
• Strong knowledge of 21 CFR 820, 21 CFR 11, European medical‑device regulations, GMP, and ISO standards.
• Proven experience delivering validation and process‑improvement projects.

Required skills

• Six Sigma / Black Belt
• Lean Manufacturing
• Statistical Process Control (SPC)
• Design of Experiments (DOE)
• Measurement System Analysis
• Reliability engineering
• Process validation
• GMP compliance
• ISO 13485 knowledge
• FDA regulatory expertise (21 CFR 820, 21 CFR 11)