Job Title: Engineer
Location: Suzhou, Jiangsu, China
Job Type:
FULL-TIME
Availability:
15-30 days
Experience Level:
6-8 Years
Role Overview:
Plan and execute Manufacturing Engineering (ME) projects to support factory validation after construction, including equipment and process validations (such as sterilization validation). After factory and product approval for manufacturing, focus on improving quality, yield, and capacity. Support business needs by assisting in the transfer of new products to Production. Develop strong relationships and communication with key equipment and material vendors in China, Thailand, Singapore, and Japan.
Duties and Responsibilities:
Plan and execute projects to improve quality, yield, process efficiency, and capacity related to Intraocular Lens (IOL) manufacturing.
Lead operations in new product or process development and transfer activities.
Act as trainer for ISO-related testing.
Execute IQ/OQ/PQ for new equipment.
Design new equipment, jigs, and fixtures to enhance process efficiency and sustainability; manage and maintain equipment and tooling.
Initiate and execute change control processes.
Manage end-of-life issues for product materials and components.
Support projects through effective communication with vendors.
Train and mentor engineers and assistant engineers within the ME team.
Requirements:
Minimum 3 years of experience in the pharmaceutical or medical device industry.
Experience with Class III medical devices is preferred.
Strong background in machining, inspection, packaging, and automation within medical device or pharmaceutical manufacturing.
Effective communication skills in English and Mandarin; proficiency in Japanese is an advantagw
Basic project management skills, with the ability to lead or participate in cross-functional teams (R&D, ME, Production, Supply Chain) for new product and process introduction.
Ability to independently plan, prepare, and execute feasibility studies, validation protocols, and reports.
Basic understanding of lean manufacturing principles and ability to apply lean methods for process improvement.
Bachelor's degree in Engineering or related field.
Prior experience in product-related roles or in the medical device industry is preferred
Approximately 10–15% travel to Thailand, Singapore, and Japan.