Senior V&V Engineer, Medical Devices (Onsite)

TechClub Inc

Milpitas (CA)

On-site

USD 100,000 - 150,000

Full time

43 hours ago

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Job summary

TechClub Inc. in Milpitas, CA, is seeking a senior Verification & Validation (V&V) Engineer with Medical Device industry experience to lead protocol development, execution, and reporting in a regulated environment.

You will develop and review V&V protocols, execute tests, document observations, deviations, and outcomes, and prepare validation reports. Collaboration with Quality, Regulatory Affairs, and Engineering is essential as you work with legacy systems and ensure compliance with FDA, ISO

Qualifications

Experience in medical device development and quality processes.
Ability to develop, execute, and report V&V activities.
Familiarity with FDA/ISO 13485/IEC 62304 compliance.
Experience with legacy operating systems and legacy tech.
Strong communication and problem-solving skills.

Responsibilities

Develop, review, and execute V&V protocols and test plans.
Prepare validation reports and ensure accurate documentation of results.
Perform protocol execution and document observations, deviations, and outcomes.
Support verification and validation activities throughout the product lifecycle.
Collaborate with cross-functional teams including Engineering, Quality, and Regulatory Affairs.
Work with legacy systems and technologies as required.
Ensure compliance with applicable quality and regulatory requirements.