Job Description
Job Title: Senior Process Development Engineer Location: Bray Co. Wicklow Company: Global company specialising in the development, manufacture, and marketing of clinical diagnostic products About the role: The ideal candidate will play a critical role in developing and optimizing manufacturing processes for our continuous glucose monitoring systems. This position involves working closely with cross-functional teams to ensure our products meet the highest standards of quality, reliability, and performance. Develop and optimize manufacturing processes for CGM systems, ensuring efficiency, scalability, and cost-effectiveness. Provide technical support for the production team, troubleshooting and resolving process-related issues. Ensure processes comply with regulatory requirements and quality standards (e.g., ISO, FDA). Lead and participate in continuous improvement initiatives to enhance process reliability and product quality. Manage process development projects, ensuring timelines, budgets, and deliverables are met. Requirements and Skills: Bachelor’s degree in Engineering, Chemistry, Biotechnology, or a related field. Advanced degree preferred. Minimum of 5 years of experience in process development, preferably in the medical device or biotechnology industry. Proven experience with continuous glucose monitoring systems or similar technologies is highly desirable. Strong understanding of manufacturing processes, including chemical, mechanical, and electronic assembly. Proficient in using process development tools and software (e.g., CAD, Minitab, statistical analysis tools). Familiarity with Good Manufacturing Practices (GMP) and regulatory requirements for medical devices. Six Sigma Green Belt or Black Belt certification is a plus. Relevant professional certifications (e.g., ASQ Certified Quality Engineer) are advantageous. #J-18808-Ljbffr