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.
