Manufacturing Engineer

HERO Recruitment; Galway; On-site; EUR 55,000 - 63,000; Full time

Job summary

HERO Recruitment in Galway City seeks a Manufacturing Engineer to support the introduction and transfer of innovative medical technologies into full-scale commercial manufacturing. You will establish robust, compliant production processes and lead validation activities in a hands-on, regulated environment.

Key responsibilities include leading NPI/product transfer projects, establishing repeatable process controls, driving CI-based improvements, and ensuring adherence to GMP, regulatory, quality,

Qualifications

• Degree in engineering or equivalent technical discipline.
• 3–5+ years in Manufacturing Engineering within medical device or regulated healthcare manufacturing.
• Experience supporting NPI, product transfer, or scale-up activities.
• Strong validation experience (IQ/OQ/PQ) and knowledge of ISO standards.

Responsibilities

• Lead engineering activities within NPI and product transfer projects.
• Establish robust, repeatable manufacturing process controls.
• Drive process optimisation using structured CI methodologies.
• Ensure GMP, regulatory, quality, and EHS standards compliance.
• Lead equipment and process validations (IQ, OQ, PQ).
• Investigate and resolve non-conformances and contribute to risk assessments.

Skills

NPI

Product transfer

CI methodologies

Regulatory compliance

GMP knowledge

IQ/OQ/PQ

ISO standards

Education

Level 8 Honours Degree in Engineering

Job description

Manufacturing Engineer

Location: Galway City

Salary: €55,000-€63,000

This newly created Manufacturing Engineer role supports the introduction and transfer of innovative medical technologies into full-scale commercial manufacturing. You'll establish robust, compliant production processes and lead validation activities in a hands-on, regulated manufacturing environment.

Key Responsibilities

• Lead engineering activities within NPI and product transfer projects.
• Establish robust, repeatable manufacturing process controls.
• Drive process optimisation using structured CI methodologies.
• Ensure compliance with GMP, regulatory, quality, and EHS standards.
• Lead equipment and process validations (IQ, OQ, PQ).
• Investigate and resolve non-conformances and contribute to risk assessments.

Qualifications & Experience

• Level 8 Honours Degree in Engineering (or equivalent technical discipline).
• 3–5+ years' experience in Manufacturing Engineering within medical device or regulated healthcare manufacturing.
• Proven experience supporting NPI, product transfer, or scale-up activities.
• Strong validation experience (IQ/OQ/PQ).
• Knowledge of regulatory and quality requirements (e.g. ISO standards).