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Biomedical Engineering Companies jobs in Galway, County Galway

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    • 2–7 years of manufacturing engineering experience (level dependent).
    • The Manufacturing Engineer supports the design, development, validation, and continuous…
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    • Work with cross-functional teams to identify and resolve production/engineering issues.
    • The successful candidate will be responsible for providing daily support…
    • BE + ME Mechanical Engineering.
    • Provide daily technical support to the department.
    • Carry out a project and report progress as agreed by Supervisor/Manager.
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    • BE + ME Mechanical Engineering.
    • BE + ME Electronic & Computer Engineering.
    • Provide daily technical support to the department.
    • You will build, guide, and enhance the engineering team to meet future needs.
    • You will support the hiring, training, and mentoring of the engineering team.
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    • The successful candidate will partner with R&D, Manufacturing, Quality, and Regulatory Affairs teams to ensure medical devices are designed, developed, verified…
    • Responsible for other projects as assigned by the company.
    • Liaison with quality and engineering both internal to the plant and externally within the corporation…
    • Work with cross-functional teams to identify and resolve production/engineering issues.
    • The successful candidate will be responsible for providing daily support…
  • View similar jobs with this employer
    • The successful candidate will partner with R&D, Manufacturing, Quality, and Regulatory Affairs teams to ensure medical devices are designed, developed, verified…
    • Provide ongoing engineering support to the manufacturing line, ensuring efficient and stable operations.
    • Be part of a growing organization committed to quality,…
    • Act as project leader for medium- to large-scale manufacturing projects to ensure manufacturing success through cross-functional collaboration with other…
    • Perform duties in compliance with the company Quality Management System (QMS), applicable regulatory requirements, and company policies.

Job Post Details

Manufacturing Engineer Hybrid - job post

Cregg Recruitment Ltd
4.4 out of 5 stars
Galway, County Galway

Location

Galway, County Galway

Full job description

Manufacturing Engineer - Hybrid

CREGG are hiring for a Manufacturing Engineer to work with a large Medical Device company in Galway. Hybrid role

For more information contact Mark: 086 1901346 or markhalligan@cregg.ie

Job Summary
The Manufacturing Engineer supports the design, development, validation, and continuous improvement of manufacturing processes for medical devices. This role ensures products are manufactured efficiently, safely, and in compliance with regulatory requirements such as FDA, ISO 13485, and GMP.

Key Responsibilities

Process Development & Optimization

  • Design, develop, and improve manufacturing processes for medical devices

  • Create process flow diagrams, work instructions, and standard operating procedures (SOPs)

  • Optimize processes for quality, yield, cost, and cycle time

  • Support transfer of products from R&D to manufacturing

Validation & Compliance

  • Lead and execute process validation activities (IQ/OQ/PQ)

  • Ensure compliance with FDA regulations (21 CFR 820), ISO 13485, and GMP requirements

  • Support audits and inspections (FDA, notified bodies, internal audits)

  • Maintain manufacturing documentation in accordance with quality system requirements

Equipment & Tooling

  • Specify, qualify, and maintain manufacturing equipment and tooling

  • Collaborate with suppliers on equipment design and installation

  • Troubleshoot equipment and process issues to minimize downtime

Cross-Functional Collaboration

  • Work closely with Quality, R&D, Regulatory Affairs, Supply Chain, and Operations teams

  • Support design for manufacturability (DFM) and design for assembly (DFA) efforts

  • Assist in root cause investigations and corrective actions (CAPA)

Continuous Improvement

  • Apply Lean, Six Sigma, or other continuous improvement methodologies

  • Drive cost reduction, waste elimination, and efficiency improvements

  • Analyze process data and implement corrective and preventive actions

Required Qualifications

Education

  • Bachelor’s degree in Manufacturing Engineering, Mechanical Engineering, Biomedical Engineering, Industrial Engineering, or related field

Experience

  • 2–7 years of manufacturing engineering experience (level dependent)

  • Experience in a regulated industry, preferably medical devices

  • Hands-on experience with process validation and documentation

Technical Skills

  • Knowledge of FDA QSR, ISO 13485, GMP

  • Experience with IQ/OQ/PQ validation

    INDTRAC

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