Project Engineer

2 days ago

Kulim, Kedah, Malaysia BD Malaysia Full time 80,000 - 120,000 per year

Job Description Summary

Project Engineer position for site support of eDHR software implementation. Expected project period 2 years

Job Description

P2-14099

  • Technical Implementation & Integration

  • Lead the deployment and integration of eDHR systems across production lines or healthcare facilities.

  • Ensure systems are configured to meet operational, regulatory, and quality requirements.

  • Collaborate with IT and software vendors to ensure seamless data flow and system interoperability.

  • Project Planning & Coordination

  • Develop detailed project plans, timelines, and resource allocations.

  • Coordinate cross-functional teams including Quality, Operations, IT, and external vendors.

  • Track milestones and ensure timely delivery of project phases (design, testing, go-live).

  • Compliance & Documentation

  • Ensure eDHR systems comply with industry regulations

  • Maintain accurate documentation of system configurations, validations, and change controls.

  • Support audits by providing traceable and validated digital records.

  • Training & Support

  • Develop training materials and conduct sessions for end-users.

  • Provide ongoing support and guidance to ensure effective system adoption.

  • Monitor user feedback and implement system enhancements as needed.

  • Quality Assurance & Testing

  • Collaborate with QA teams to validate system functionality and data integrity.

  • Conduct performance testing and ensure the system meets quality standards.
  • Support UAT (User Acceptance Testing) and resolve any identified issues.

Qualifications:

  • Bachelor's degree in engineering, Computer Science, Information Technology, or related field.
  • 3–5 years of experience in medical device manufacturing, MES implementation, or digitalization projects.
  • Hands-on experience with Apriso configuration, deployment, and support.
  • Experience with MES systems, preferably Dassault Systèmes Apriso.
  • Familiarity with eDHR systems, digital manufacturing, and system integration.
  • Understanding of database systems, data flow.
  • Proficiency in system validation, and quality assurance testing.
  • Proven ability to lead cross-functional teams (Quality, IT, Operations, Vendors).
  • Strong skills in project planning, resource allocation, and timeline management.
  • Experience managing digital transformation or IT implementation projects in regulated environments.
  • Familiarity with medical device regulations in Malaysia and globally (e.g., MDA, FDA, EU MDR).
  • Experience in documentation, change control, and audit support.
  • Excellent communication skills for stakeholder engagement and user training.
  • Ability to develop training materials and conduct end-user sessions.
  • Strong analytical and problem-solving skills to address system feedback and enhancements.
  • Experience working in multinational environments or with global teams.

Required Skills

Optional Skills

.

Primary Work Location

MYS Kedah - Bard Kulim (Malaysia)

Additional Locations

Work Shift

MY3 Normal 8a-4.45p Group 26 (Malaysia)

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