Địa điểm

Location
  • Lương

    Thỏa thuận

  • Kinh nghiệm

    Không yêu cầu kinh nghiệm

  • Số lượng

    1

  • Hết hạn nộp

    06/06/2026

Phúc lợi

  • Chế độ bảo hiểm
  • Du Lịch
  • Chế độ thưởng
  • Chăm sóc sức khỏe
  • Đào tạo
  • Tăng lương

Mô tả Công việc

Job Description: 
Activities and relevant KPI Targets: The following processes are key to Design quality Engineer performance within Nextern and between Nextern and our key customer collaborators. This role must be proficient at achieving outcomes on-time, with high quality documentation content, and cross-functional  team awareness/support (internal & external). 
1. Product and Process Qualification & Validation. 
2. Engineering change process validation and monitoring. 
3. Equipment (Functional Test, Assembly Fixtures, Manufacturing Aids, etc.) Selection & Qualification. 
4. Create Quality Process Control for new product. 
5. Return Material Authorization (Intra Nextern) 
6. Non-Conforming Material Processing (Manufacturing, Supplier, & Engineering Change Causes) 
7. Create required documentation that relevant to product specifications and requirements (Process flow, control plan, inspection criteria, etc.) 
8. Perform Test Method Validation for testing, inspection, measurement process. 
9. Partners with Product Development team on developing schedule, risk registers and actively supports business strategy. Ensures that solutions are successfully implemented by removing organizational or technical roadblocks 
10. Take lead the Product Development team to execute the need of each project deliverable and deliverable interdependencies and where in the Product Development Process cycle they need to be planned and completed

11. Working knowledge of project deliverables and ability to generate with no guidance. Understands the impact of decisions and needs of other functions. Able to exercise judgment to set direction for medium to high complexity projects. 
12. Able to set directions for Risk Management activities on a project of medium complexity and execute required deliverables. Works independently to ensure Design Control deliverables are properly informed by RM and RM documentation is properly updated as a result of Design Control activities. 

Yêu Cầu Công Việc

Qualification and Skill: 
1. Engineering degree or higher (Prefer candidate have experience in medical device) 
2. Minimum 2 years’ experience in process quality management and 2 years’ experience in Engineering or design. 
3. Have experience in the technical field of plastic molding, medical components for bodily fluid treatments, metal stamping, PCBA is preferred. 
4. ISO9001:2015 or ISO13485 certification,  ISO13485 certification is preferred) 
5. Experience in Solving problem (follow 8D). 
6. Experience in statistical and FMEA. 
7. Experience in product qualification and process creation and qualification. 
8. Experience in Test Method Validation execute. 
9. Experience in process capability and control, Minitab. 
10. Good in excel (especially VBA), word, excel and PowerPoint. 
11. Language: must be fluent in English (written & verbal). 
12. Good in presentation and communication, especially in English. 
13. Knowledge about improving concept (Kaizen, 6 sigma, lean manufacturing, etc.). 
Physical Demands and Work Environment:  
• Able to work overtime and accept meeting at night several times weekly. 
• Able to work under high pressure. 
• Able to work in clean room. 
Technical Expertise: The following product types will require technical leadership and expertise to contain issues, determine root cause of issues, drive corrective actions internal to Nextern and collaboratively 
with customer collaborators, and collaborate with the supplier management organization on effective corrective/preventive actions to be implemented by the supplier, as needed.  
• Therapy medical components for bodily fluid treatments 
• Printed Circuit Board Assemblies 

• Pneumatic Pumps & Valves 

• Cables & wired interconnect assemblies 
• Molded Plastic Parts (including pad/laser print suppliers) 
• Gluing, Mating, and Fastening Processes for Enclosures 
• Displays 
• Power Supplies 
• Mechanical fastener & chassis components 
• Electromechanical connectors & fasteners 

Thông tin khác

  • Bằng cấp: Đại học
Địa điểm Factory C-1B-D5, My Phuoc 3 Industrial Park, Thoi Hoa Ward, Ben Cat, Binh Duong Province
Thông tin công ty
  • Qui mô công ty:
  • Loại hình hoạt động: 100% vốn nước ngoài
  • Website: https://nextern.com
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Giới thiệu về công ty

Nextern collaborates with innovators, clinicians, and companies to create, iterate, optimize, and manufacture best-in-class medical devices. We structure our relationships to perfectly align incentives, allowing you to leverage our expertise…so you focus on yours.

* How we work:

  • We perfectly align incentives from the beginning.
  • We support product development at every stage.
  • We vertically integrate design with manufacturing.

Nextern Viet Nam is a 100% wholly owned by the United State Company. Our new factory will open in Binh Duong on June 2019. We are specialized in manufacturing and distributing medicial devices. You can visit our https://www.nextern.com for more information.

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