Manufacturing Engineer

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

Benefits offered by this job

Competitive salary

Career development

Lean/Six Sigma training

Comprehensive benefits package

Job summary

Sigmar Recruitment is seeking a Manufacturing Engineer for an onsite role in Galway within the medical devices sector. You will support the manufacturing line, lead root-cause investigations, and ensure CAPAs are effectively implemented to maintain quality and compliance.

You will collaborate with multidisciplinary teams on process development, validation activities (IQ/OQ/PQ), and documentation. A strong Lean/Six Sigma background and GMP awareness are essential.

Qualifications

• 3–5 years hands-on experience in the medical device or pharmaceutical production environment.
• Knowledge of ISO 13485, MDR, and FDA regulatory requirements within a QMS.
• Strong analytical and troubleshooting skills, ownership mentality, and teamwork.

Responsibilities

• Provide ongoing engineering support to the manufacturing line to ensure stable, efficient operations.
• Lead root cause analysis for complex equipment/process issues and implement CAPAs.
• Manage process and equipment change control with validation and documentation per QMS standards.
• Identify and deploy new tools, jigs, fixtures, or process improvements to boost quality and efficiency.
• Drive continuous improvement initiatives using Lean or Six Sigma methodologies.
• Collaborate with cross-functional teams on risk management, development, and validation projects (IQ/OQ/PQ).
• Develop, review and maintain technical documents, SOPs, and work instructions.
• Support GMP-compliant, safe, and orderly production environments and training.

Skills

Lean Manufacturing

Six Sigma Green Belt

Problem solving

Autonomous work

Communication

Documentation

Education

Bachelor’s degree in Engineering

Job description

Manufacturing Engineer

About Your New Employer

• Join a pioneering company in the development of advanced medical devices for global markets.
• Work at the forefront of medical technology with a highly skilled, cross-functional team and a strong culture of continuous improvement.
• Be part of a growing organization committed to quality, innovation, and compliance with international standards such as ISO 13485, FDA 21 CFR Part 820, and EU MDR directives.
• This job is fully onsite.

About Your New Job

As a Manufacturing Engineer, you will:

• Provide ongoing engineering support to the manufacturing line, ensuring efficient and stable operations.
• Lead troubleshooting and root cause analysis for complex equipment, processes, or material issues, implementing effective corrective and preventive actions (CAPAs).
• Manage process and equipment change control, including all validation and associated documentation, per rigorous QMS and regulatory standards.
• Identify and deploy new tools, jigs, fixtures, or process solutions to improve manufacturing efficiency, product quality, and reliability.
• Drive and deliver continuous improvement initiatives using Lean Manufacturing, Six Sigma, or other recognized methodologies.
• Collaborate with multidisciplinary teams in risk management, process development, and equipment or product validation projects (IQ, OQ, PQ).
• Develop, review, and maintain technical documentation, SOPs, work instructions, and visual standards.
• Ensure a GMP-compliant, safe, and orderly work environment, and support ongoing staff training on manufacturing processes.

What Skills You Need

• Bachelor’s degree in Engineering (Mechanical, Manufacturing, Biomedical, or related disciplines).
• 3-5 years of hands-on experience in the medical device or pharmaceutical industry, with a background in production equipment operation/maintenance and process improvement.
• Sound knowledge of ISO 13485, MDR, and FDA regulatory requirements; experience working within a QMS.
• Strong analytical and troubleshooting skills, ownership mentality, and ability to work both autonomously and collaboratively.
• Proficiency in process improvement tools (Lean, Six Sigma- Green Belt an advantage).
• Excellent communication, teamwork, and documentation capabilities.
• Strong organizational skills and ability to juggle multiple priorities in a fast-moving production environment.

What's on Offer

• Competitive salary, commensurate with experience.
• Opportunities for ongoing career growth, professional development, and training (including further Lean/Six Sigma certification).
• Be part of innovative teams driving exciting product development projects and see your impact on products that matter.
• Comprehensive benefits package.