Anmol Agrawal

• Responsible for defining the verification strategies based on the scope of the new product requirements description.
• Accountable for complete verification activities (consisting of Requirement Impact Assessment, Design Verification Protocol and Report, Test method validation) of robotic systems, including electromechanical systems, and support for software requirements.
• Ensured the requirements tracing to maintain traceability between system-level requirements and their corresponding verifications, utilizing the V-model approach for traceability.
• Analyzed design or requirement information for equipment or systems.
• Conducted testing to evaluate functionality and optimization, applying statistical methods and data-driven approaches to ensure accuracy and performance validation.
• Assisted in troubleshooting issues related to product design.
• Supported project management efforts through effective communication and coordination.
• Led the systematic optimization of verification processes to enhance workflow efficiency and reduce engineer-induced error margins across the system development lifecycle.
• Led the training and development of the team through statistical learning sessions.

• Lead (as the functional lead) the remediation team for the redesign of the tray system for carrying surgical instruments.
• Lead the team of human factors engineers for usability assessment.
• Conducted formative and summative evaluations for the knee portfolio.
• Worked in remediation of Risk Table to align with ISO 13485 & ISO 14971. Updating hazards, hazardous situations, and identifying hazard causes and their risk control measures.

• Responsible for the design and development of new products (plastics, metals, and their combination in a system) in the knee portfolio (implants and instruments) of the joint replacement division while maintaining the design control documents (DFMEA, DIOVV, and RT).
• Accountable for taking the instruments through the NPDP (New Product Development Process) cycle by proactively completing the Design Reviews for three instruments, with the completion of multiple Engineering Analyses and Tolerance Analyses (using GD&T (ASME Technologist certified)) and CAD modeling using Creo Parametric.
• Responsible for two verification activities, including the test plan, verification protocols, and reports of the new product, including fixture design and development, utilizing statistical analyses.
• Measurement system analysis (Repeatability, Reproducibility, Accuracy, and Relative Biases) for test method validation.
• Actively interacted with surgeons to support the team in the validation of the new design. Responsible for developing the validation protocol and the validation report.
• Collaborated with different cross-functional teams, such as Quality, Sterility, and Regulatory, to provide input on new product design.
• Supported quality in developing risk tables as per ISO quality standards (harm, hazard, occurrence of harm, RCMs, causes, risk regions).
• Responsible for the remediation of the existing product line, including more than 300 SKUs, to adhere to EU regulations as per the Global Quality Management System.

Other Responsibilities:

• On-boarded 2 batches of Interns under my supervision for bringing new talents up to the skills required in an organization.
• Successfully managing the skill development lab for learning of clinical aspects of Primary Knee Arthroscopy. Organized a Surgeons Cadaver lab in Bangalore.
• Mentored and trained new hires on the NPDP cycle and primary knee surgical procedure.
• Organized the GD&T training for engineers by collaborating with SAE International team. The training was successfully completed with a batch of 20 engineers with different backgrounds.

• Worked on concept generation through a collection of customers' voices.
• Supported engineers in designing and developing instruments used in knee arthroscopy through the New Product Development Process.
• Supported in drafting the design control documents, such as Engineering Analysis, DFMECA, and DIOVV.
• Responsible for supporting tolerance analysis using GD&T.