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.
