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.
Requirements
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
Benefits
- Benefits Competitive salary
- Professional and Friendly Working Environment, chance to attend employee's training and development programs
- Premium healthcare Insurance (In Vietnam) & Business travel insurance Health, social & unemployment insurance (following Government regulation)
- Company trip, New Year party, Team building
- Occasion-based offerings: Birthday, New year, Mid-Autumn
Skills Required
- Engineering degree or higher
- Minimum 2 years experience in process quality management
- Minimum 2 years experience in Engineering or design
- Experience in plastic molding and medical components
- ISO9001:2015 or ISO13485 certification
- Experience in 8D problem solving
- Experience in statistical methods and FMEA
- Experience in product qualification and process creation
- Experience in Test Method Validation
- Experience in process capability and control
- Good in Excel, Word, PowerPoint
- Fluent in English (written & verbal)
- Good presentation and communication skills
- Knowledge of Kaizen, 6 sigma, lean manufacturing
What We Do
Nextern collaborates with innovators, clinicians, and device partners to create, iterate, optimize and manufacture best-in-class medical devices. We bring an unmatched core competence in medical device product design and development through manufacturing as a leverageable asset to collaborators like you, who are focused on accelerating the commercial side of the business.
