Project Engineer - #1127413

Job Responsibilities:

•  Manage project schedule: To plan, coordinate, and oversee the assembly processes of medical devices or equipment, ensuring that production meets design specifications, regulatory standards 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.

Job Requirement :

•  Diploma in Engineering or equivalent

• 2 years of relevant working experience

• Strong understanding of Medical device regulations and standards

• Strong technical skills

• Good communication and interpersonal skills

• Able to start work immediate or short notice