Project Engineer, CM

About the Role

We are looking for a dedicated project engineer to join our team. The Project Engineer will be responsible for overseeing engineering projects specialize in contract manufacturing in medical device, from conception through to completion. You will work closely with cross-functional teams to identify and resolve manufacturing issues. To establish the process flow, inspection criteria of all the processing steps. improve production and demonstrate excellent project management skills to ensure that projects are completed on time, within budget, and meet quality standards.

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.

Qualifications:

• Degree or Diploma in mechanical engineering, Electrical Electronic & Engineering or a related field.
• Minimum of 1~2 years of working experience in project coordinator/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 quality management systems.

*Please indicate your current and expected salary in your resume.