Katalyst Healthcares and Life Sciences
Responsibilities:
- Verification & validation Engineer will have the following responsibilities:
- A strong technical background and experience g in the medical device industry (Translation of User/Business Needs to System Requirements, Requirements Management, System Architectural Development, Functional Modeling, Systems Integration, Statistical Test Design, Verification and Validation, Hazards Analysis, and Failure Modes Effects Analysis), and/or other engineering disciplines within the medical device industry.
- Lead verification and validation activities for new and existing medical devices, ensuring compliance with FDA 510k, ISO 13485, and FDA 21CFR Part 820 regulations.
- Working knowledge of IEC 60601-1 3rd Edition and related particular & collateral standards is essential.
- Document system and product-level requirements; managing 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.
- 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.
- Meticulousness and strong organizational skills.
- Proficiency in relevant software tools and technologies.