Manufacturing Engineer

Mason Alexander; Galway; On-site; EUR 45,000 - 65,000; Full time

Job summary

Mason Alexander is seeking a Manufacturing Engineer to join a Galway-based cardiovascular medical device company on a 6-month contract. You will develop, optimise and validate manufacturing processes, working with R&D, Quality and Operations to ensure robust, scalable production in a fast-paced startup environment.

The role involves IQ/OQ/PQ, process validation, documentation, and continuous improvement across the manufacturing lifecycle while ensuring ISO 13485 and GMP compliance.

Qualifications

• Bachelor's degree in manufacturing/related engineering field.
• 3 years of manufacturing engineering experience in medical devices.
• Experience with process validation (IQ/OQ/PQ) and equipment qualification.
• Familiarity with ISO 13485, GMP and medical device quality systems.
• Strong documentation and cross-functional communication skills.

Responsibilities

• Develop and optimise manufacturing processes for product development and pilot manufacturing.
• Support transfer of products from R&D to manufacturing.
• Prepare and execute IQ/OQ/PQ and process validation activities.
• Create manufacturing documentation: work instructions, procedures, SOPs.
• Investigate issues and implement CAPAs and corrective actions.
• Lead continuous improvement to improve process capability and efficiency.
• Support DFM activities and collaborate with suppliers and contract manufacturers.
• Contribute to risk management activities (PFMEA, process risk assessments).
• Provide technical support to production builds and verification activities.

Skills

Problem solving

Documentation

Communication

Continuous improvement

Lean manufacturing

Design for Manufacturability

Education

Bachelors in Manufacturing Eng

Tools

IQ/OQ/PQ

GMP

Job description

An innovative cardiovascular medical device company based in Galway is seeking a Manufacturing Engineer to join its growing engineering team on a 6-month contract.

Working within a collaborative start-up environment, you will play a key role in supporting the development, optimisation and validation of manufacturing processes as the technology progresses towards clinical and commercial manufacture. This is an excellent opportunity for an engineer who enjoys working across product development, manufacturing and quality within a fast-paced, highly innovative medical device company.

The Manufacturing Engineer will support manufacturing process development, equipment qualification, process validation and continuous improvement activities. You will work closely with R&D, Quality and Operations to ensure manufacturing processes are robust, scalable and compliant with medical device regulations.

This role would suit an engineer who enjoys hands-on manufacturing support while contributing to the commercialisation of an exciting Class III cardiovascular device.

Responsibilities:

• Develop, implement and optimise manufacturing processes to support product development and pilot manufacturing.
• Support the transfer of products and processes from R&D into manufacturing.
• Prepare and execute equipment qualifications (IQ/OQ/PQ) and process validation activities.
• Develop manufacturing documentation including work instructions, manufacturing procedures and standard operating procedures.
• Investigate manufacturing issues using structured problem-solving methodologies and implement effective corrective actions.
• Lead continuous improvement initiatives to improve process capability, product quality and manufacturing efficiency.
• Support Design for Manufacturability (DFM) activities throughout product development.
• Work closely with suppliers, contract manufacturers and internal stakeholders to support manufacturing readiness.
• Participate in risk management activities including PFMEA and process risk assessments.
• Support CAPA investigations, non-conformance reviews and engineering change activities.
• Ensure manufacturing activities comply with ISO 13485, GMP and applicable regulatory requirements.
• Provide technical support to production builds, engineering studies and verification activities.

Qualifications & Experience Requirements:

• Degree in Manufacturing Engineering, Mechanical Engineering, Biomedical Engineering or a related engineering discipline.
• 3 years of manufacturing engineering experience within the medical device industry.
• Experience supporting manufacturing process development in a regulated environment.
• Knowledge of process validation (IQ/OQ/PQ) and equipment qualification.
• Experience with continuous improvement tools such as Lean Manufacturing, Six Sigma or structured problem solving.
• Understanding of Design for Manufacturability principles.
• Familiarity with ISO 13485, GMP and medical device quality systems.
• Strong documentation and technical report writing skills.
• Excellent communication skills with the ability to work effectively across multidisciplinary teams.
• Previous experience within cardiovascular, catheter-based or implantable medical devices would be advantageous.
• Experience working in a start-up or fast-growing medical device company would be highly desirable.

This is a 6 month contract role based on-site just outside Galway city.