Project Engineer
BD
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.
- 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.
Vacancy posted a month ago
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