Project Engineer

About the Company

Yixin Precision

is a vibrant company which was established in 1995 and incorporated as a private company in 2001.

We provide services in mold making, plastic injection molding and assembly. Mold making include specialty mold for metal injection molding (MIM) and die casting molds. The end molded components could be use for disposable medical devices or microfluidics chips.

About the Role:

The Project Engineer will be responsible for overseeing engineering projects specializing in contract manufacturing in medical devices, from conception through to completion. You will work closely with cross-functional teams to identify and resolve manufacturing issues.

Responsibilities:

• Manage project schedule: To plan, coordinate, and oversee the assembly processes of medical devices or equipment, ensuring production meets design specifications, regulatory standards in ISO 13485 (Medical Devices QMS) and FDA 21 CFR Part 820 (QSR) and project deadlines.
• Lead or support IQ/OQ/PQ (Installation Qualification, Operational Qualification, and Performance Qualification) activities.
• Develop and maintain engineering documentation, including procedures, processes and quality plan, drawings, and specifications.
• Ensure work performed within desired quality and stipulated schedule.
• Ensure customer's specification and requirements understood and executed as to provide good engineering solutions communicating with customers, interpreting their needs and requirements.

Qualifications:

• Diploma / Bachelor's degree in mechanical engineering, Electrical Electronic & Engineering or a related field.
• Minimum of 2 years of working experience in project coordination/management or in related field.

Required Skills:

• Strong understanding of Medical device regulations and standards.
• Strong written and verbal communication skills in English.
• Strong technical skills, including knowledge of engineering principles and practices.

Preferred Skills:

• Experience in contract manufacturing.
• Familiarity with cross-functional team collaboration.