Design Quality Senior Engineer

Position Summary:

Nextern, an US based innovator in developing and manufacturing class II & III electro-mechanical medical devices is seeking a Design Quality Engineer for its Binh Duong, Vietnam location. Join an organization with a passion for commercializing smart, effective and patient centric medical device solutions.

This position is responsible for quality control of new products that are designed by Nextern US and running a trial in Nextern VN and control the quality of components that will be submitted to US site.

This position is responsible for quality control of changes on existing products that are producing in Nextern VN.

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.

13. Capable of driving strategic business process improvement activities. Provides input to new project scope and can guide the business development team on strategic approach to quoting new projects.

1. Engineering degree or higher (Prefer candidate have experience in medical device)

2. Minimum 4 years’ experience in process quality management and 2 years’ experience in Engineering or design.

3. Have experience on technical field of plastic molding, metal stamping, PCBA is preferred.

4. ISO9001:2015 certification is mandatory (ISO13485 certification is preferred)

5. Experience in Solving problem (follow 8D).

6. Experience in FMEA as a leader.

7. Experience in product qualification and process creation and qualification.

8. Experience in Test Method Validation execute.

9. Expert in process capability and control, Minitab.

10. Excellent in excel (especially VBA), word, excel and PowerPoint. Can use measurement equipment such as Vision Measuring Machine (VMM), Coordinate Measuring Machine (CMM),…

11. Language: must be highly fluent in English (written & verbal).

12. Very good in presentation and communication, especially in English.

13. Leadership behavior is preferred.

14. 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.

• 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