Manufacturing Engineer

Role Overview

A cardiovascular medical device innovator located near Galway is looking to appoint a Manufacturing Engineer for a 6-month contract. Operating within a dynamic start-up atmosphere, this role is pivotal in supporting the advancement, optimisation, and validation of manufacturing procedures as the product advances towards clinical trials and commercial production.

Key Duties

• Develop and refine manufacturing workflows that support both product development and pilot-scale production.
• Facilitate transfer of products and processes from R&D to manufacturing stages.
• Plan and conduct equipment qualification phases including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), along with process validation efforts.
• Create detailed manufacturing documents such as work instructions, procedures, and SOPs.
• Use systematic problem-solving methods to identify manufacturing issues and initiate effective corrective actions.
• Lead initiatives aimed at continuous improvement to enhance process reliability, product quality, and manufacturing productivity.
• Contribute to Design for Manufacturability (DFM) activities during product design and development.
• Collaborate closely with suppliers, contract manufacturers, and internal teams to ensure manufacturing readiness.
• Engage in risk management activities including Process Failure Mode and Effects Analysis (PFMEA) and other risk assessments.
• Assist with CAPA investigations, handle non-conformance reviews, and manage engineering change processes.
• Ensure compliance with ISO 13485 standards, Good Manufacturing Practices (GMP), and regulatory requirements related to medical devices.
• Provide technical assistance for production builds, engineering tests, and verification projects.

Qualifications and Experience

• Bachelor’s degree in Manufacturing Engineering, Mechanical Engineering, Biomedical Engineering or a related field.
• At least 3 years of professional experience in manufacturing engineering within the medical device sector.
• Sufficient background in manufacturing process development under regulatory conditions.
• Familiarity with process validation techniques including IQ, OQ, and PQ, as well as equipment qualification.
• Experience applying continuous improvement methodologies such as Lean Manufacturing, Six Sigma, or structured problem-solving tools.
• Knowledge of Design for Manufacturability concepts.
• Understanding and experience working with ISO 13485, GMP, and medical device quality systems.
• Strong technical writing and documentation abilities.
• Effective communicator capable of productive collaboration within multidisciplinary teams.
• Experience in cardiovascular, catheter-based, or implantable medical devices is a plus.
• Exposure to start-up or rapidly expanding medical device companies is highly advantageous.

Additional Information

This position is offered as a six-month contract based on-site near Galway city. The role is ideally suited to engineers who enjoy hands-on involvement in manufacturing support and contributing towards the commercialisation of advanced Class III cardiovascular devices.