Project Engineer

BD Malaysia; Kulim; On-site; MYR 80,000 - 100,000; Full time

Job summary

A leading medical device company in Malaysia is seeking a Project Engineer for site support of eDHR software implementation. In this role, you will lead the deployment and integration of systems, develop project plans, and ensure compliance with regulations. Candidates should have a Bachelor's degree in engineering and 3–5 years of experience in medical device manufacturing or digital projects. Excellent communication skills and the ability to manage cross-functional teams are necessary for success in this role.

Qualifications

• 3–5 years of experience in medical device manufacturing or digitalization projects.
• Hands-on experience with Apriso configuration and deployment.
• Experience with MES systems, preferably Dassault Systèmes Apriso.
• Familiarity with medical device regulations in Malaysia and globally.

Responsibilities

• Lead deployment and integration of eDHR systems across production lines.
• Develop detailed project plans, timelines, and resource allocations.
• Ensure compliance with industry regulations and maintain documentation.
• Conduct training sessions for end-users and provide ongoing support.
• Collaborate with QA teams to validate system functionality.

Skills

Project planning

Collaboration with cross-functional teams

Strong analytical skills

Communication skills

Problem-solving skills

Education

Bachelor’s degree in engineering or related field

Tools

Apriso

MES systems

Job description

Job Description Summary

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

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 and 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.

Primary Work Location

MYS Kedah - Bard Kulim (Malaysia)

Work Shift

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