Innovative Biomedical Engineer with 7+ years of experience designing, developing, and testing medical devices and systems that improve patient outcomes and healthcare delivery. Expertise in biomaterials, medical imaging technologies, and regulatory compliance with a proven track record of bringing novel medical solutions from concept to commercialization. Adept at collaborating with cross-functional teams including clinicians, researchers, and manufacturing specialists to translate clinical needs into effective technical solutions while ensuring compliance with FDA and international standards.

Senior Biomedical Engineer

• Lead development of next-generation implantable cardiac monitoring system, managing cross-functional team of 8 engineers through design, prototyping, and verification phases that resulted in 40% reduction in device size while extending battery life by 35%

• Spearhead design and implementation of novel biosensor technology for continuous glucose monitoring, developing algorithms that improved measurement accuracy by 28% and reduced false alarms by 45% in clinical trials

• Collaborate with regulatory affairs team to prepare comprehensive FDA 510(k) submissions for Class II medical devices, successfully obtaining clearance for 3 products with average review time 30% below industry standard

Biomedical Engineer

• Designed and optimized minimally invasive surgical instruments for endoscopic procedures, implementing biomechanical improvements that enhanced precision by 25% and reduced tissue trauma in clinical evaluations

• Conducted comprehensive verification and validation testing of medical devices according to ISO 13485 standards, developing test protocols that identified critical design flaws early in development cycle and reduced redesign costs by $350K

• Collaborated with manufacturing engineers to improve production processes for cardiovascular stents, implementing design for manufacturability principles that increased yield by 18% and reduced production costs by $1.2M annually

R&D Engineer

• Developed biocompatible materials and coatings for implantable neurostimulation devices, conducting extensive in vitro and in vivo testing that demonstrated 65% reduction in inflammatory response compared to previous generation

• Created computational models to simulate electrical field distribution in neural tissue, optimizing electrode configurations that improved therapeutic efficacy by 30% while reducing power consumption

• Participated in design review meetings with clinical advisors and marketing teams, translating physician feedback into technical specifications that aligned product development with market needs and clinical requirements

Master of Science in Biomedical Engineering

• Concentration: Medical Devices and Imaging

• Thesis: 'Novel Biomaterials for Controlled Drug Delivery in Orthopedic Applications' - Developed polymer-based delivery system that demonstrated sustained release over 60 days in vitro

• Relevant Coursework: Biomaterials Science, Medical Device Design, Tissue Engineering, Biomedical Imaging, Regulatory Science, Biostatistics, Biomechanics

Bachelor of Science in Bioengineering

• Honors: Magna Cum Laude; Dean's List (all semesters); Bioengineering Department Scholarship Recipient

• Senior Design Project: 'Wearable Biosensor for Continuous Hydration Monitoring' - Received Innovation Award at Engineering Design Showcase

• Relevant Coursework: Biomechanics, Bioelectronics, Systems Physiology, Medical Instrumentation, Biomaterials, Signal Processing, Control Systems

Implantable Cardiac Monitoring System

• Led development of miniaturized implantable cardiac monitor with advanced arrhythmia detection algorithms, reducing false positive alerts by 65% compared to previous generation devices

• Designed novel electrode configuration and sensing circuitry that improved signal quality in noisy environments, enabling reliable monitoring during physical activity and reducing need for signal filtering

• Implemented low-power wireless communication protocol that extended battery life to 5+ years while maintaining daily data transmission capability to patient monitoring app

Continuous Glucose Monitoring Biosensor

• Developing non-invasive glucose monitoring technology using optical sensing and machine learning algorithms that demonstrated 92% correlation with blood glucose measurements in preliminary studies

• Designed wearable form factor that improved user comfort and adherence, with 85% of study participants reporting preference over traditional monitoring methods

• Created adaptive calibration system that reduces drift over time, extending sensor reliability to 14 days without recalibration compared to industry standard of 7 days

Bioresorbable Vascular Scaffold

• Developed polymer-based bioresorbable scaffold for coronary applications with optimized mechanical properties that provided adequate vessel support while degrading predictably over 24 months

• Designed and executed comprehensive mechanical testing program that characterized scaffold performance under physiological conditions, identifying critical design parameters for optimization

• Collaborated with materials scientists to modify polymer chemistry and processing methods, achieving 40% improvement in radial strength while maintaining controlled degradation profile

Regulatory Affairs Certification (RAC)

• Comprehensive certification in medical device regulatory requirements and submission processes

• Expertise in FDA regulations, international standards, and quality management systems

• Knowledge of regulatory strategy development and compliance throughout product lifecycle

Certified Quality Engineer (CQE)

• Demonstrated expertise in quality engineering principles and practices for medical devices

• Proficiency in statistical methods, process improvement, and quality management systems

• Skills in design validation, reliability analysis, and corrective/preventive actions

Design for Six Sigma (DFSS) Green Belt

• Advanced training in applying Six Sigma methodologies to product design processes

• Expertise in requirements management, concept generation, and design optimization

• Skills in risk assessment, design verification, and process capability analysis

Member

• Active participant in Medical Devices Special Interest Group, contributing to discussions on emerging technologies and regulatory considerations

• Regular presenter at annual BMES conferences on topics including implantable sensors, biomaterials, and medical device design methodologies

• Reviewer for BMES journal, providing technical evaluation of submitted research papers in medical device development

Committee Member

• Contribute to development of industry standards for testing and characterization of medical devices and biomaterials

• Participate in working groups focused on implantable sensors and electronic medical devices

• Collaborate with industry experts to establish consensus standards that balance innovation with safety and efficacy requirements

Guest Lecturer

• Deliver annual lectures on 'Medical Device Development: From Concept to Commercialization' for graduate-level biomedical engineering courses

• Mentor student teams on medical device design projects, providing industry perspective and technical guidance

• Participate in program's Industry Advisory Board, helping shape curriculum to address evolving industry needs and technological trends