Job Details

Overview

Location: National City, CA

Salary: $75,000.00 - $104,000.00

Contract position for Verification & Validation Engineer in the medical device industry. Responsible for leading verification and validation activities, ensuring regulatory and quality compliance, and collaborating with cross-functional teams.

Responsibilities

• Lead verification and validation activities for new and existing medical devices, ensuring compliance with FDA 510k, ISO 13485, and FDA 21CFR Part 820 regulations.
• Document system and product-level requirements; manage changes via team review, approval, and release process.
• Develop and execute test protocols, plans, and reports for medical devices and cleaning/disinfecting products.
• Collaborate with cross-functional teams to ensure design and development activities meet regulatory and quality requirements.
• Conduct risk assessments and develop mitigation strategies for verification and validation activities.
• Prepare documentation and support regulatory submissions, including FDA 510k submissions.
• Participate in design reviews and provide input on design for manufacturability and testability.
• Ensure all verification and validation activities are properly documented and maintained according to company quality systems.
• Stay up to date with industry trends, standards, and regulatory changes related to medical devices and cleaning/disinfecting products.
• Identify opportunities for process improvements and implement best practices in verification and validation.
• Train and mentor junior engineers on verification and validation processes and regulatory requirements.
• Experience in Risk Management a plus.

Qualifications / Requirements

• Bachelor's or master's degree in biomedical engineering, Mechanical Engineering, or a related field.
• Minimum of 3-5 years of experience in the medical device industry, with a focus on R&D, verification, and validation.
• In-depth knowledge of FDA 510k submission process and requirements.
• Strong understanding of ISO 13485 and FDA 21CFR Part 820 regulations.
• Firsthand experience with verification and validation processes for medical devices.
• Experience with cleaning and disinfecting products for medical devices is highly desirable.
• Strong analytical and critical thinking skills; excellent written and verbal communication skills.
• Ability to work effectively in a team environment; meticulous and well-organized.
• Proficiency in relevant software tools and technologies.

Seniority level

• Associate

Employment type

• Contract

Industry

• Pharmaceutical Manufacturing