Process Engineer
- Cork
- Contract
- Full-time
- Design and develop robust, high-yield manufacturing processes that ensure consistent product quality.
- Optimize equipment and process technologies to support the successful transfer of reliable, efficient processes into full-scale manufacturing.
- Collaborate with R&D teams to support the design and seamless transition of new medical devices from development through validation and into production.
- Manage and support external vendors in the design, build, and installation of manufacturing equipment-from initial concept through to factory integration.
- Drive continuous improvement and innovation in existing equipment and processes to support New Product Introductions (NPIs).
- Prepare and maintain detailed process and manufacturing documentation.
- Author and execute validation and qualification protocols (IQ/OQ/PQ) for equipment and processes.
- Champion ongoing process improvement initiatives to ensure high standards of product quality and efficiency.
- Coordinate with cross-functional teams to support both current and future manufacturing needs.
- Act as a site-level expert in specific manufacturing technologies and support knowledge development within the team.
- Oversee the commissioning and scaling of new manufacturing technologies, with a focus on microcatheter production.
- Conduct risk assessments with Environmental Health & Safety (EHS) teams when introducing new equipment, materials, or chemicals to reduce environmental impact.
- Bachelor's degree (Level 8) in Engineering or Science (Manufacturing, Mechanical, Electronic, Production, or related disciplines).
- Minimum of 3 years of experience in the medical device industry.
- Strong interpersonal and communication skills, with demonstrated leadership qualities.
- Excellent analytical and problem-solving capabilities.