R&D Verification & Validation Engineer

Job Title: R&D Verification & Validation Engineer (Medical Device)

Job Description

Essential Skills

• Bachelor’s Degree in Engineering or equivalent knowledge.
• At least 2 years of experience with verification or validation processes.
• Proficiency in test method validation, verification, and validation, and testing protocols.
• Experience with medical devices and root cause investigations.
• Ability to set up acceptance criteria when needed and analyze software.
• Experience with failure investigations and new product development.

Responsibilities

• Lead test method development activities, including test fixture design, equipment acquisition and equipment qualifications
• Test and evaluate new and existing products of moderate to advanced complexity.
• Interpret data and evaluate product performance to verify product requirements and design inputs.
• Develop verification and validation protocols, and issue reports for regulatory audits, submissions, and requests.
• Conduct root cause investigations to determine defects and performance problems and lead product design and failure investigations.
• Provide risk assessments, identify mitigating factors, and check for adherence to regulatory standards.