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Key Highlights as a Senior Biomedical Engineer:

  • 🛠️ Developed Cutting-Edge Diagnostic Devices: Designed and optimized the Breath Sampler and Spectrometer for non-invasive disease detection.

  • 📏 Ensured Regulatory Excellence: Expert in FDA and ISO 13485 compliance for medical device design and manufacturing.

  • ⚙️ Risk Management: Mitigated potential risks through FMEA, hazard analysis, and custom risk matrices to enhance product safety and performance.

  • 🧾 Regulatory Compliance: Authored design history and risk management files to support product validation and regulatory submissions.

  • 🧪 Improved Product Reliability: Proposed and implemented corrective actions to enhance the performance of diagnostic devices.

  • 🌍 Collaborated with Clinical Teams: Worked closely with healthcare professionals to integrate and troubleshoot devices in clinical settings.

  • 🔍 Focused on Innovation: Advanced technologies for volatile organic compounds (VOC) analysis and biomarker detection to improve early disease diagnostics.

My work involves designing, assembling, and validating breath collection and diagnostic devices, identifying product anomalies, supporting clinical testing, and ensuring compliance with regulatory and quality standards. I worked hands on with 2 medical devices:

Breath Sampler:

  • Precise Design Execution: Ensured strict adherence to detailed blueprints and engineering specifications to achieve optimal functionality.

  • Performance Troubleshooting: Identified and resolved technical issues during the development process, addressing challenges related to airflow dynamics, sample integrity, and environmental factors.

  • Enhancing Reliability: Proposed and implemented design enhancements to improve durability, consistency, and accuracy of biomarker collection across diverse patient populations.

  • Cross-Functional Collaboration: Worked with manufacturing teams to align the assembly process with design specifications and conducted iterative testing to refine device performance.

  • Regulatory Alignment: Designed the breath sampler to meet FDA and ISO 13485 requirements, ensuring compliance with medical device standards.

  • Impact: Successfully delivered a device that enables accurate, non-invasive collection of breath samples, paving the way for early detection of diseases such as cancer and enhancing diagnostic reliability in clinical settings.

Spectrometer:

Spectrometer_edited.jpg

  • Design and Development: Led the enhancement of the design and functionality of a spectrometer to improve its ability to analyze VOCs in breath samples for early disease detection.

  • Performance Enhancement: Optimized the spectrometer’s core components, including its detection sensitivity and signal-to-noise ratio, to ensure precise identification and quantification of VOC biomarkers.

  • Design Refinements: Collaborated with cross-functional teams to redesign internal mechanisms and implement advanced algorithms for improved accuracy and reliability in detecting disease-specific biomarkers, such as those linked to breast cancer.

  • Workflow Integration: Worked closely with clinical teams to ensure the spectrometer's seamless integration into diagnostic workflows, making it user-friendly and efficient in real-world clinical environments.

  • Regulatory Compliance: Ensured that the spectrometer met stringent FDA regulations and ISO 13485 standards by incorporating design controls, risk management practices, and documentation required for medical devices.

  • Prototyping and Testing: Led the iterative prototyping process, conducting extensive bench tests and clinical validations to assess and refine the spectrometer’s ability to deliver consistent and reproducible results under various conditions.

  • Impact: Delivered a robust and high-performing spectrometer capable of analyzing complex breath samples with enhanced accuracy, contributing to the early and non-invasive detection of diseases like cancer and improving diagnostic reliability in clinical practice.

Key Strengths & Expertise:

Risk Management & Regulatory Compliance

  • ✅ Comprehensive Risk Assessments: Conducted FMEA and hazard analysis to identify and mitigate potential design and development risks.

  • 📊 Risk Matrices Development: Designed and implemented risk matrices to ensure compliance with ISO standards, improving device safety and performance.

  • 📜 Regulatory Expertise: Authored and maintained critical documents, including design history files and risk management files, to support product validation and regulatory submissions.

  • 🔒 Standards Adherence: Ensured all devices met FDA and ISO 13485 regulations throughout the development lifecycle.

Device Development & Innovation

  • 💡 Diagnostic Device Design: Specialized in creating innovative non-invasive diagnostic devices, including breath samplers and spectrometers using CAD software (Fusion 360 & SOLIDWORKS)

  • 🔬 Innovation in Biomarker Analysis: Advanced technologies for early disease detection, improving accuracy and reliability in VOC detection.

  • 🛠️ Product Optimization: Improved device durability and reliability through troubleshooting and iterative design enhancements.

Clinical Collaboration & Troubleshooting

  • 🩺 Clinical Integration: Partnered with clinical teams to deploy, test, and troubleshoot devices in healthcare facilities, ensuring seamless performance in real-world environments.

  • 🔧 On-Site Problem Solving: Addressed technical challenges during clinical trials and product deployment to maintain reliability and performance.

Core Technical Skills

  • ⚙️ Risk Analysis: Proficient in FMEA, hazard analysis, and risk mitigation for complex systems.

  • 📂 Design Documentation: Experienced in managing design history files and regulatory documents to support compliance and validation.

  • 🤝 Cross-Functional Team Collaboration: Proven ability to work with engineering, regulatory, production, and clinical stakeholders to drive product success.

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