Katalyst CRO
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
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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
#J-18808-Ljbffr