Process Engineer

Job Description

We are seeking a highly skilled and motivated Process Engineer to join our team at Morepen Laboratories Ltd, a leading organization dealing in manufacturing of home diagnostics medical devices. The Process Engineer will play a crucial role in optimizing manufacturing processes, ensuring product quality, and driving continuous improvement initiatives. This role requires a strong understanding of manufacturing principles, medical device regulations, and process improvement methodologies. Role & responsibilities Process Optimization: * Analyze and optimize manufacturing processes to improve efficiency, reduce costs, and enhance product quality. * Develop, implement, and validate process improvements, including new equipment, procedures, and technologies Technical Support: * Provide technical support to production teams to resolve process issues, equipment malfunctions, and quality concerns. * Collaborate with cross-functional teams, including R&D, quality assurance, and production, to ensure smooth integration of new products and processes. Compliance and Documentation: * Ensure all processes comply with regulatory requirements, including FDA, ISO 13485, and other relevant standards. * Develop and maintain process documentation, including Standard Operating Procedures (SOPs), Work Instructions, and Process Flow Diagrams. Process Development: * Design and execute process validation studies, including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). * Identify and implement best practices for process design, control, and monitoring Preferred candidate profile Qualifications: Education: Bachelors degree in Engineering (Electrical, ECE). Advanced degree or certifications (e.g., Six Sigma, Lean) preferred. Experience: Minimum of [3-5] years of experience in process engineering within a medical device or regulated manufacturing environment. Perks and benefits