Field Validation Engineer

Field Validation Engineer

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.

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.