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We are seeking a highly skilled and motivated R&D Engineer to join our team. The successful candidate will play a crucial role in the verification and validation of medical devices, including FDA 510k projects, ISO 13485 compliance, and FDA 21CFR Part 820 adherence. The responsibilities will also encompass the verification and validation of infusion pump products.
Qualifications:
Education: Bachelor’s or master’s degree in biomedical engineering, Mechanical Engineering, or a related field.
-Minimum of 3+ 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
Technical Must Haves: Minitab, Verification Testing, FDA 510k, ISO 13485, 21 CFR Part 820
Responsibilities
A strong technical background and experience within systems engineering 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.
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.
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.
Identify opportunities for process improvements and implement best practices in verification and validation.
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