We are seeking a talented and driven Process Development Engineer to join our cutting-edge Medical Device manufacturing team in Cork. In this role, you will play a pivotal part in the development, scale-up, and commercialization of life-changing medical technologies, including advanced hydrogels, embolic coils, and endoscopy valves.
You will bridge the gap between initial product design and full-scale commercial manufacturing, taking projects from Design Verification through Process Validation, and successfully launching them into production.
Key Responsibilities
Process Development & Scale-Up: Develop, optimize, and scale scalable manufacturing solutions for complex medical devices from design verification through to full commercial launch.
Validation & Qualification: Author and execute comprehensive validation protocols (IQ/OQ/PQ) and equipment qualifications for chemical formulation, automated manufacturing, and vision inspection systems.
Cross-Functional Collaboration: Partner closely with international R&D teams (including potential on-site collaboration with US-based teams) to refine product specifications and optimize processes.
Capital Equipment Projects: Support capital projects involving the design, procurement, installation, and qualification of next-generation manufacturing systems and automation equipment.
Regulatory Compliance: Ensure all process development activities and documentation strictly align with medical device regulatory standards to enable seamless transition to commercial production.
Key Requirements
Education: Honors Bachelor's Degree (Level 8) in Engineering (Mechanical, Biomedical, Chemical, Manufacturing, or a related discipline).
Experience: Minimum of 2 years of experience in process development, manufacturing engineering, or validation within a regulated industry (Medical Devices strongly preferred).
Technical Skills: Experience with equipment qualification, automated manufacturing systems, vision inspection technology, or chemical formulation processes is highly desirable.
Soft Skills: Strong cross-functional collaboration skills, excellent communication, and the ability to travel internationally if required for project collaboration.
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