Process Development R&D Engineer

To be responsible for engineering activities in product improvement/engineering projects; performs engineering analysis, equipment and process set up, carry out risk assessments and validations as well as production implementation for completed projects.

Responsibilities

• Participate in product improvement/engineering projects, and responsible for engineering activities.
• Perform risk analysis (FMEA) to define process flow and control plan.
• Perform equipment qualification and process validation for product improvement/engineering projects.
• Ensure projects are implemented in line with the schedule and budget.
• Optimize new/improved process parameters to further improve product quality and the overall equipment effectiveness.
• Explore new process to improve product quality or productivity.
• Be responsible for the successful transfer of new/improved process/methodologies into the production with good process margins and inline controls.
• Involved in hands-on execution of manufacturing operations.
• Provide operational training for operators or related personnel.
• Manage administrative duties as well as ad-hoc projects assigned by immediate superior.

Requirements

• Minimum a Bachelor Degree in Mechanical/Industrial/Manufacturing/Biomedical Engineering related disciplines or equivalent.
• Good mechanical or material aptitude and knowledge.
• Good experience of manufacturing process and cGMP manufacturing.
• Experience of operational management and lean manufacturing.
• Clean room/environment control experience.
• 2 years of overall work experience would be added an advantage.
• Fresh graduate is acceptable.
• Excellent English-speaking & writing skills
• Multi-lingual: Chinese (Mandarin), other languages are an asset
• Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry.
• Ability to write professional reports, business correspondence, and procedure manuals.