Nasrin Nesha

Experience

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  Wayne State University College of Engineering

  Aug 2018 - May 2019

  BME Freshmen Capstone Project: Design Development and Validation and Verification Engineer

  • Reverse engineered a rollator walker with a team of 4 peers to make it motorized. Led a team to conducted market research, designed and manufactured a testable prototype for FDA approval. • Drafted and presented a DHF (Design History report) report meeting FDA and GMP standards using Excel, Word, and PowerPoint. Researched competitors’ products with appliances functions and documented patents used in design.

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  Wayne State University

  Jan 2019 - Aug 2022

  • Gathered data on all aspects required for the FDA approval of this device especially focusing on the validation testing required for approval. • Created a 501(k)-report documentation for FDA approval. • Researched all aspects of the design process to make sure all regulatory requirements of the FDA and GMP are met. • Worked on designing an alternative to percutaneous endoscopic gastrostomy (PEG) tube placement in patients with difficulty swallowing or esophageal dysphagia or esophageal cancer. • Involved in image processing and analysis of US and PA images. • Designed experiments evaluating the utility and accuracy of the image-guided system.

  • Design Validation and Verification Testing Engineer for TRACE Blood Pressure Monitor

    Jan 2022 - Aug 2022

  • Student Researcher for Ultrasound and Photoacoustic Imaging Guidance of Gastric Tube Placement

    Jan 2019 - May 2022
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  Wayne State University College of Engineering

  Aug 2019 - May 2020

  BME Sophomore Capstone Project: Design Development and Validation and Verification Engineer

  • Designed a device to detect the probability of concussion in football players with a team of 6 people. Met with clients, organized the team, conducted market and field research, designed graphics in NX CAD, and created a working testable prototype. • Drafted and presented a DHF (Design History report) and DOE (Design of Experiments) report meeting FDA and GMP standards using Excel, Word, and PowerPoint comparing competitors’ products with appliances functions and documented patents used in design. Show less

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  Wayne State University College of Engineering

  Aug 2020 - May 2022

  BME Senior Capstone Project: Design Development and Validation and Verification Engineer

  • Developed an improved biomaterial coating that protects transplanted islet cells from environmental stressors and facilitates optimal glycemic control in patients with Type 1 Diabetes during an islet cell transplantation procedure. • Designed a multilayered, spherical microcapsule composed of polyvinylpyrrolidone (PVPON) and tannic acid (TA), treated with 3 pharmacologically active drugs, that would preserve pancreatic islet function in the short- and long-term. • Met with Physicians and researchers in the field, organized the team, conducted market and field research, designed graphics in NX CAD, and created a working testable prototype. • Drafted and presented a DHF (Design History report) and DOE report meeting FDA and GMP standards using Excel, Word, and PowerPoint. Show less

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  BioPrecision Laboratories, Inc

  Aug 2023 - Jan 2024

  Lab Quality and Validation Engineer

  • Perform routine laboratory procedures according to COLA standards. • Maintain quality results by running standards and controls, verifying equipment function through routine equipment maintenance and advanced trouble shooting, calibrating equipment utilizing approved testing procedures, monitoring quality control measures and protocols. • Use training and clinical judgment to evaluate instrument performance and quality control results to determine the accuracy and reliability of analytic data before it is released. Standardize, calibrate, operate, perform preventive maintenance and limited troubleshooting on select laboratory equipment or instruments within established parameters. Show less

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  Zimmer Biomet

  Jan 2024 - now

  Manufacturing Process Engineer

  • Developed, executed, and reported CFR 820.75 compliant process validations using Good Manufacturing Practice (GMP) and Good Documentation Practices (GDP).• Executed and documented validation protocols (IQ, OQ, PQ) for manufacturing equipment, processes, facilities, and utilities, ensuring compliance with GMP, FDA, and ISO 13485 standards. • Designed and optimized new manufacturing processes, integrating lean methodologies and statistical tools to improve efficiency, reduce waste, and enhance quality. • Conducted PFMEA to identify risks, implement mitigation strategies, and ensure process reliability and product quality. • Performed Gage R&R studies to analyze measurement system variability and recommended improvements for enhanced process accuracy.• Coordinated and verified validation documentation to ensure alignment with cGMP compliance and regulatory requirements. • Delivered on-the-job training (OJT) for operators, ensuring knowledge transfer and adherence to validated procedures and operational standards. • Performed First Article Inspections (FAIs) to validate product conformity and ensure a smooth transition to production.• Led cross-functional collaborations to develop innovative solutions for complex manufacturing challenges, focusing on cost-effectiveness and quality assurance. Show less