Position Overview:

The V&V Engineering Lead will be responsible for establishing and leading the Verification and Validation project, focusing on mechanical, optical, and biological testing. This role is crucial in ensuring that medical devices meet all regulatory requirements and internal quality standards.

Responsibilities:

• Manage the Design Verification and Validation project, focusing on mechanical, optical, and biological testing.
• Develop and implement comprehensive V&V strategies and plans.
• Lead the execution of verification and validation activities.
• Oversee external testing activities, coordinating with domestic and international labs.
• Develop testing and analysis methods for the entire product life cycle.
• Report defects and issues found during testing and collaborate in root cause analysis.
• Collaborate to create and maintain design control documentation.
• Stay current with industry trends, emerging technologies, and regulatory requirements.

Qualifications:

• B.S. Degree in Mechanical / Biomedical Engineering or related field from a reputable university.
• Minimum of 5 years of experience in engineering roles within the medical device industry.
• Experience in planning and executing design verification and validation activities of invasive medical devices, with a focus on mechanical and biological testing.
• Excellent analytical and problem-solving skills.
• Effective communication and teamwork abilities.
• Motivated and self-driven individual.