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

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Primary Work Location

MYS Kedah - Bard Kulim (Malaysia)

Additional Locations

Work Shift

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