Job Title: Process Development Engineer
Location: Parkmore, Galway
Company: My client is a medical device company developing an innovative device to support the heart. Heart support devices are used by interventional cardiologists to stabilize patients in cases of acute heart failure (cardiogenic shock) or during high-risk coronary procedures (high-risk PCI). Their goal is to improve upon current assist devices by offering a more effective and less invasive solution. Founded in 2018 as a Radboud UMC spin-off, they have a diverse, enthusiastic team based in the Netherlands and Galway, Ireland.
Job Description:
Support the development and implementation of manufacturing and assembly processes for the company’s pVAD catheter. Provide design feedback and collaborate with suppliers of catheter components. Work closely with device development, characterization teams, and Quality to realize full project potential. The ideal candidate will possess an entrepreneurial spirit, persistence, resourcefulness, and hands-on experience in cardiovascular device development and manufacturing processes.
Responsibilities:
* Develop manufacturing processes, materials, and methods within the product development team.
* Design, specify, procure, and qualify process fixtures and equipment.
* Create Work Instructions and supporting documentation such as calibration and maintenance procedures.
* Execute process characterization and validation activities.
* Become a technical expert in product assembly and manufacturing, providing guidance to team members.
* Ensure quality compliance in all work aspects.
* Collaborate with cross-functional teams and external partners to meet design and validation requirements.
* Support cleanroom setup, validation, and process evaluation.
* Identify opportunities to implement new manufacturing technologies.
* Manage project plans, tasks, and deadlines using structured problem-solving and statistical analysis.
Skills and Qualifications:
* Minimum three years of medical device development experience.
* Degree in engineering disciplines such as polymer, mechanical, manufacturing, or biomedical engineering.
* Experience in fabrication and manufacture of catheter-based medical devices; large calibre delivery systems experience is advantageous.
* Proficiency in product and process development, validation, and manufacturing documentation.
If interested, please apply or contact Thomas Gallagher at 087 0612325 or thomas.gallagher@lifescience.ie.
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