Senior Manufacturing Engineer (Medical Device)

About the role

We are seeking a Senior Manufacturing Engineer to join the Engineering Projects Team of a leading global medical device manufacturer in Cork. The role will drive operational efficiency, cost reduction and process improvement across a regulated, high‑volume manufacturing environment.

Key responsibilities

• Act as the End‑to‑End Engineering representative for projects covering quality, cost‑savings, capacity and validation initiatives.
• Lead the full project life‑cycle – scoping, design, implementation, execution and close‑out.
• Identify and deliver cost‑saving opportunities related to scrap reduction, consumables usage and labour efficiency.
• Collaborate with Operations, Quality, EHS, Automation, Finance and Maintenance to secure project funding and align requirements.
• Develop project documentation, including scope, design specifications and execution plans.
• Present project status and funding needs to senior leadership regularly.
• Define process inputs and outputs, establish operational ranges and support equipment and process validation (IQ/OQ/PQ).
• Ensure effective risk management, design controls and issue resolution in partnership with Quality and Validation functions.
• Provide clear reporting on progress, escalating risks and issues as needed.
• Maintain compliance with GMP, ISO and relevant regulatory standards while upholding health, safety and environmental requirements.

Required profile

• MSc in Engineering or Science.
• 7+ years experience in medium to high‑volume manufacturing (e.g., orthopaedics, food, oil & gas, paint).
• Minimum 2 years experience in a regulated environment (FDA/ISO).
• Hands‑on engineering experience supporting trials, experiments and on‑site project implementation.
• Proven track record of delivering engineering or continuous‑improvement projects.

Required skills

• Lean manufacturing.
• Project management.
• Good Manufacturing Practice (GMP) compliance.
• ISO standards.
• Equipment and process qualification (IQ/OQ/PQ).
• Risk management.
• Design controls.
• Knowledge of 21 CFR Part 820.
• Knowledge of 21 CFR Part 11.
• EU medical device regulations.