Engineer - Process Engineering

Are you passionate about manufacturing, process improvement, and solving technical challenges? Join our team in Hanoi as a Process Engineer and help drive the development and optimization of Injection Molding and Extrusion processes for life-saving medical devices.
In this role, you'll collaborate with cross-functional teams and global experts to introduce new products, improve production processes, support validation activities, and ensure the highest standards of quality and efficiency.
If you enjoy continuous improvement, and are excited to make a meaningful impact in healthcare, we'd love to hear from you!
Job Description
1 . Engineering responsible of development and implementation for Injection Molding & Extrusion projects
- In charge of Injection Molding & Extrusion projects: new products, new materials, new designs, or modified processes. [protected info] engineering function of the project (technical expert).
- Define / create process setting parameters for new process (engineering test, collaboration with R&D, Global process engineering). Responsible to perform DoE for new Mold, issue and update process specification.
- Perform feasibility tests to assess technical and production feasibility before full implementation.
- Prepare and maintain process engineering packages, including process flow, layout, equipment list, and technical parameters.
- Execute FAT & SAT for Injection Molding and Extrusion equipment, including test preparation, execution, deviation handling, and acceptance reporting.
- Ensure equipment compliance with technical specifications, safety, and quality requirements prior to production release.
2. Change control handle (materials changes, equipment change...)
- Participate in Global Change Control (GCC) activities related to Injection Molding and Extrusion processes.
- Perform feasibility studies, trials, and validations for proposed process changes.
- Assess risks and impacts of process changes on quality, compliance, and production.
- Coordinate change implementation and provide technical input during approval stages.
3. Process Documentation & Validation Support
- Prepare and maintain process documentation for new Injection Mold and Extrusion tube projects.
- Develop and update SOPs, Work Instructions, and Risk Analysis (e.g. PFMEA).
- Support validation activities, including IQ/OQ/PQ, as required.
- Ensure all documentation meets internal, regulatory, and audit requirements.
4. Subject Matter Expert (SME) for Injection Molding and Extrusion processes
- Act as the key technical contact point with global Injection Molding and Extrusion experts.
- Exchange best practices, lessons learned, and technical know‐how between global and local teams.
- Collect and communicate BBVN process pain points and challenges to global experts for alignment and resolution.
- Support continuous process improvement through global-local collaboration.
- Others as assigned by Managers.