Process Development Engineer

This role partners closely with R&D Engineering and Manufacturing teams to design and implement reliable, high-performance manufacturing processes for medical device production. The position involves managing multiple projects related to large-scale automation equipment for device assembly and testing, taking processes and equipment from concept through to full implementation.

Key Responsibilities

• Develop high-yield, high-capability manufacturing processes.
• Optimize equipment and process performance to ensure efficient, repeatable transfer to manufacturing.
• Collaborate with R&D engineering to support new medical device design and transition validated products into production.
• Engage with vendors on equipment design and builds, providing support from early concept through on-site deployment.
• Design and enhance equipment and processes to support New Product Introductions (NPIs).
• Prepare, maintain, and update technical and manufacturing documentation.
• Author and execute validation and qualification protocols.
• Drive continuous quality and process improvements.
• Partner with cross-functional teams on current and future process development initiatives.
• Build and maintain specialist expertise within the Cork site.
• Lead commissioning of new microcatheter manufacturing technologies, including production ramp-up, validations, and continuous improvement initiatives.
• Identify and assess opportunities for advancing medical device technology.
• Collaborate with EHS to evaluate new equipment, processes, and materials for environmental impact, ensuring risks are minimized.

Qualifications & Experience

• Bachelor's degree (Level 8) in Engineering or Science (Manufacturing, Mechanical, Electronic, Production, etc.).
• Minimum of 3 years' experience in the medical device industry.
• Strong interpersonal, communication, and leadership skills.
• Proven analytical and problem-solving abilities.
• Hands-on experience in at least one of the following areas:
• Design of Experiments (DOE)
• Process development and characterization
• Process troubleshooting and problem solving
• Process validation
• DMAIC methodology
• Equipment validation
• New product introduction (NPI)