Manufacturing Engineer: Lean & Quality Med Devices

HERO Recruitment; Galway; On-site; EUR 60,000 - 85,000; Full time

Job summary

HERO Recruitment is seeking a highly capable Process Engineer in Ireland to provide daily support to production, processes, materials, and equipment. You will lead Lean initiatives, drive process improvements, and ensure GMP compliance while coordinating with engineering and quality teams.

The role requires a minimum 2 years in engineering within a regulated environment, strong teamwork, and initiative, with exposure to MES, SAP, and Windchill advantageous.

Qualifications

• HETAC Level 8 qualification in engineering or a relevant field, with relevant experience.
• A minimum of 2 years’ relevant experience in Engineering, ideally in a Medical Device or highly regulated setting.
• Process Validation (OQ/PQ).
• Knowledge of MES, SAP, Windchill is advantageous.
• Windchill CN access experience is beneficial.
• Good technical capabilities, communication, teamwork and initiative.
• Project Management experience is advantageous.

Responsibilities

• Provide technical leadership on product and process issues.
• Lead process improvement programs across people, service, quality and cost.
• Apply structured and systematic methodologies.
• Liaise with quality and engineering internally and externally.
• Participate in phase reviews and NPE meetings for new products.
• Ongoing manufacturing support to meet quality, output and cost goals.
• Maintain a capacity model and plan for required capital advances.
• Provide leadership on Lean initiatives.
• Develop and implement GMP‑compliant documentation with the team.
• Plan projects in detail for major initiatives or transfers.
• Evaluate new equipment/processes for environmental impact.
• Manage multiple projects across sites and teams.
• Demonstrate commitment to patient safety and product quality.

Skills

Technical leadership

Process improvement

Lean initiatives

Project management

Teamwork

Initiative

Education

HETAC Level 8 in engineering or relevant field

Tools

MES

SAP

Windchill

Job description

HERO Recruitment is seeking a highly capable Process Engineer in Ireland to provide daily support to production, processes, materials, and equipment. You will lead Lean initiatives, drive process improvements, and ensure GMP compliance while coordinating with engineering and quality teams.

The role requires a minimum 2 years in engineering within a regulated environment, strong teamwork, and initiative, with exposure to MES, SAP, and Windchill advantageous.