Responsibilities & Authorities:

• Lead and manage Product Verification Team for medical devices.

• Provide the verification strategy for projects.

• Reponsible for and continuously improve Design Verification & Validation planning, execution, and reporting process.

• Oversight the testing program cross the sites.

• Ensure the products in compliance with industry standards and regulations.

• Develop and implement comprehensive testing protocols, analyze test results, and provide detailed reports.

• Collaborate with other departments to address quality issues or debug issue.

• Communicate with Customers for testing protocol, criteria, and report.

• Train and mentor team members.

• Have the experience in EMC, Safety, Reliability, debug, and provide the consultancy for problem solution.

• Coordinate the resources and planning the outsourcing (3rd party) for Biocompatibility Testing / Sterilization Validation in regulated environment.

• Manage the testing labs and plan for lab certification or procedure.

• Manage and monitor dept KPI to be achieved and budget planning.

Must Have:

1. Bachelor’s degree in Engineering, Science, Medical, or a related field.

2. At least 7 years’ work experience in product verification of medical devices.

3. Familiar with verification process including Verification/Testing plan, protocol, report and records.

4. Familiar with IEC 60601 series, ISO 10993, and relevant standards for medical devices.

5. Able to communicate the product verification activities with stakeholders.

6. English listening, speaking, reading and writing skills.

7. Proven leadership and team management skills.

8 Strong analytical and problem-solving abilities.

9. Excellent communication and interpersonal skills.