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

.
The Project Engineer will be responsible for overseeing engineering projects specialize in contract manufacturing in medical device, from conception through to completio

n.

Responsibilit

• ies:
  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 deadl
• ines.Lead or support IQ/OQ/PQ (Installation Qualification, Operational Qualification, and Performance Qualification) activi
• ties.Develop and maintain engineering documentation, including procedures, processes and quality plan, drawings, and specificat
• ions.Ensure work performed within desired quality and stipulated sche
• dule.Ensure customer's specification and requirements understood and executed as to provide good engineering solutions communicating with customers, interpreting their needs and requirem

ents.

Qualific

• ations:
  Degree or Diploma in mechanical engineering, Electrical Electronic & Engineering or a relate
• d field.Minimum of 12 years of working experience in project coordinator/management or in relate

d field.

Requir

• ed 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.

Pref

• erred Skills:
  Experience in contract
• manufacturing.Familiarity with quality manag

ement systems.
Please indicate your current and expected salary, which type of work pass is required in