Project Engineer (E-DHR)

Becton Dickinson; Kulim; On-site; MYR 150,000 - 200,000; Full time

Job summary

A global medical technology company is hiring a Project Engineer for their e-DHR project in Kulim, Malaysia. The role involves leading the deployment and integration of eDHR systems, ensuring compliance with regulatory standards, and coordinating cross-functional teams. Candidates should have a Bachelor's degree in engineering or related field, along with 3-5 years of relevant experience in digital transformation projects. Strong skills in project planning and quality assurance are essential. Join a team that encourages personal and professional growth.

Qualifications

• 3-5 years of experience in medical device manufacturing or digitalization projects.
• Hands-on experience with implementing MES and digital manufacturing.
• Familiarity with eDHR systems and data flow understanding.

Responsibilities

• Lead deployment and integration of eDHR systems.
• Develop project plans and coordinate cross-functional teams.
• Ensure compliance with industry regulations and manage audits.

Skills

Project planning

System validation

Quality assurance

Analytical skills

Communication

Education

Bachelor's degree in engineering, Computer Science, or related field

Tools

Apriso

MES systems

Job description

Overview

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become amaker of possiblewith us.

We are hiring! Join us as a Project Engineer for e-DHR project for Quality Department (Fixed Term – 2 Years) at our Kulim site.

Job Description

Responsibilities

• 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. Project management background.

Work Arrangements

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

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