Verification & Validation (V&V) Engineer

TechClub Inc; Milpitas (CA); Presencial; USD 100.000 - 150.000; Jornada completa

Descripción de la vacante

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

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Medical device industry experience

V&V

Protocol writing

Protocol execution

Report generation

Legacy Windows 2000 knowledge

Legacy technologies experience

Regulatory quality knowledge

Analytical skills

Written and verbal communication

Self-motivated

Descripción del empleo

Location: Milpitas, CA

(100% onsite Role)

Job Description:

Must Have Technical/Functional Skills

• Medical Device industry experience.
• Strong experience in protocol writing, execution, and report generation.
• Hands-on experience in Verification & Validation (V&V) activities.
• Exposure to legacy operating systems, particularly Windows 2000.
• Ability to work with legacy technologies and systems.
• Knowledge of regulated environments and quality processes.
• Strong analytical and problem-solving skills.
• Excellent written and verbal communication skills.
• Self-motivated and able to work with minimal supervision.
• Familiarity with FDA, ISO 13485, and IEC 62304 standards is a plus.

We are looking for a senior-level Verification & Validation (V&V) Engineer with experience in the Medical Device industry. The ideal candidate will be responsible for protocol development, execution, and reporting while working independently in a regulated environment.

Key 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

Role Descriptions: "Key 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."