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Description
Job Summary: Aurolab’s New Product Development (NPD) team is seeking a proactive and detail-driven Field Validation Engineer to lead and execute field-level validation activities for new medical products and devices. The candidate will play a key role in validating product performance and user acceptability under real-world clinical and field conditions, ensuring readiness for market introduction and regulatory compliance. This role requires close coordination with cross-functional teams including R&D, Quality Assurance, Regulatory, Production, and Clinical Affairs, and involves significant on-site presence at hospitals, clinics, and other field locations (both domestic and international). Key Responsibilities: Plan and Execute Field Validations: Develop detailed validation protocols for new products based on design inputs, user needs, and regulatory requirements. Execute field testing as per protocol timelines. Clinical and On-site Product Testing: Conduct product trials and evaluations in actual usage environments (hospitals, eye camps, clinics, etc.), especially for ophthalmic and surgical devices. Data Collection and Analysis: Collect quantitative and qualitative data from end-users (surgeons, technicians, nurses) and field sites. Analyze performance, usability, and safety metrics, and compile insights into structured validation reports. Cross-functional Coordination: Collaborate with R&D, Quality, Production, and Regulatory teams to close gaps identified during field validation. Provide technical feedback to influence final design modifications. Compliance and Documentation: Ensure validation procedures and documentation align with ISO 13485, CE, and other relevant medical device standards. Support documentation for regulatory submissions and audits. User Training and Support: Provide technical training and on-site guidance to end-users and support teams during field trials. Address and document real-time issues or feedback. Continuous Improvement: Identify opportunities for process improvement in field validation methodologies and implement best practices across new product launches. Qualifications & Experience: Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, Electronics, or related technical field. 1–3 years of experience in field validation or testing, preferably in the medical devices or healthcare sector. Experience working in NPD or R&D environments with exposure to product development lifecycle. Familiarity with standards such as ISO 13485, ISO 14971 (risk management), and IEC 60601 (safety of medical electrical equipment) is an advantage. Key Skills: Strong analytical and observational skills Technical understanding of medical devices and their clinical use Excellent communication and interpersonal abilities Proficiency in data analysis tools (Excel, Minitab, or similar) Documentation and reporting skills Willingness to travel frequently. Show more Show less
