Senior NPI Engineer (Process Transfer) 1 1

Responsibilities: 

• Lead process transfer activities which includes capacity expansion, equipment transfer, process quality improvements, ramp up of production, etc.
• 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.
• Ensure process compliance to regulatory standards and requirements.
• Maintain products/process (legacy and new) and update documentations.
• Resolve quality issues related to new and existing products.
• Perform technical support (active participation) and problem solving, i.e. technical evaluation of design changes and product complaints.
• Execute/support assigned tasks inclusive of product specification update, design verification and others technical or engineering activities.

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 effective and efficient product manufacturing processes.
• 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.