Senior Npi Engineer (Process Development)

Responsibilities: Lead process development activities which includes designing of the process and equipment, evaluating and optimizing the product design and manufacturing process (Design for Manufacturability and Design For Assembly). Be involved in implementation and improvement/optimization of manufacturing processes. Define process specifications, set up and qualify process equipment, including carrying out process validation. Coordinate activities of suppliers from conceptual discussion and specification through design and reviews to develop, qualify and implement manufacturing processes. Collaborate with project stakeholders to ensure process development are carried out effectively and successfully to meet project objectives. Resolve quality issues related to new and existing products, including handle NCRs and CAPAs. Execute / support assigned tasks including provide technical or engineering support plus problem solving. Requirements: A degree in Engineering Mechanical / Mechatronics Engineering or equivalent. Have at least 5 years of related working experience, preferably Medical Device Industry. Have strong technical and problem-solving skills to ensure optimal project execution and implementation. Knowledgeable on manufacturing processes, equipment, tests and process validation. Have strong communication skills, proficient in written and spoken English. Able to work independently, be structured and systematic. Able to work in a cross-cultural team. Understand documentation work is part of work nature. Must have a sense of urgency and commitment to project schedules. See it as a challenge to work in a dynamic international environment. It will be an advantage to have relevant experience from the Medical Device industry including FDA requirements, Design Control, Process Validation and ISO 13485.