Product Development and R&D

• Supported R&D, design verification, design validation, design transfer, product-change execution, and patent documentation across 15+ medical-device products, accessories, materials, and product families. 

• Ideated and Prototyped various products and product components to gauge added value

• Utilized CAD software to draw, quantify, and record prototypes and product changes

• Designed and 3D printed parts in 3D CAD software to solve problems across product development

• Initiated patent searches to determine the freedom of operation in new product markets

• Created Material Specification documentation by parsing and analyzing SDS from suppliers

• Led technical coordination with patent counsel to define unique product features for trademark, provisional, and non-provisional filings; supported at least one filing per quarter and reached annual 50-claim goal before Q2. 

• Strengthened regulated design-control traceability by translating user/stakeholder needs into design inputs, design outputs, verification/validation plans, and supporting design-history documentation. 

• Designed, Reviewed, and Maintained Records of Product, Quality, and Packaging CAD drawings

• Contacted and evaluated automated manufacturing equipment suppliers to identify solutions for product manufacturing

• Collaborated with suppliers and external manufacturers to evaluate material/component/process feasibility during early-stage product development.

• Contributed to validation readiness by aligning product prototypes and documentation to improve usability and human factors.

 

Testing, Validation, and Compliance

• Researched and implemented standardized test methods to improve repeatability, data reliability, and cross-product comparison during R&D and verification. 

• Designed Experiments utilizing established NSO-defined standards or company protocols to compare current and competitive products 

• Wrote Test Specifications and Test Procedures for Lab Technicians to complete

• Designed test fixtures and custom equipment that improved repeatability, accuracy, and efficiency of product experiments and technician execution. 

• Parsed and implemented product and test standards to determine product compliance and viability

• Performed accelerated simulated use testing to evaluate long-term product durability and safety under real-world conditions.

• Determined failure criteria and analyzed test data to determine product efficacy of design inputs and user needs during R&D and product verification/validation

• Identified MRI-compatibility risk in a product intended for MRI-room use, preventing potential patient-safety, regulatory, and liability exposure before broader implementation. 

• Helped develop an internal anthropometric database using employee volunteers, enabling more realistic prototype testing and strengthening human-factors validation readiness.

• Led First Article Inspection of new products and product changes, ensuring they match design requirements and quality control documents

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Lab Equipment and Inter-departmental Process Optimization

• Built engineering process infrastructure across test requests, design-history centralization, packaging quality control, prototype/material tracking, and user-needs development to improve traceability and execution across Product Development and Quality.

• Diagnosed tensile tester software/data issues after prior institutional knowledge was lost; coordinated with the equipment vendor and directed Manufacturing/Quality toward SOPs to preserve future tool knowledge.​

• Designed an Engineering Centralization Document linking prototype logs, risk documentation, V&V plans, related documents, user needs, and design inputs.​

• Played an active role in the reorganization of active project prototype and material naming and storage, deciding the proper nomenclature for reliably tracking prototypes and their interconnection. 

• Led refinement of user-needs development using user-centered language, clearer separation from design inputs, and inclusion of stakeholder needs to improve traceability and validation planning.​

• Introduced the inclusion of Stakeholder Needs alongside User Needs to ensure more comprehensive design inputs and interdepartmental alignment.

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Quality and Risk Management

• Developed and improved risk-management documentation, including IEC risk documentation, DFMEAs for non-electronic devices, risk mitigation protocols, and released-product risk reports.

• Determined root causes of post-release quality and in-field issues, supported CAPAs, and facilitated engineering risk-review meetings to align on product/process risks, mitigation strategies, and risk acceptability.

 

Labeling, Regulatory, and Database Management

• Determined ISO, IEC, SGS, and FDA-compliant UDI symbols for user manuals, product packaging, and shipment/use labeling requirements.

• Collaborated with Creative Design to create compliant UDI labels, box labels, product artwork, and package inserts for product shipment and use.

• Uploaded New Product information to the Global Unique Device Identification Database

• Automated portions of FDA GUDID product-information uploads using Python, BeautifulSoup, and PyAutoGUI, reducing repetitive manual regulatory-data entry and improving workflow repeatability.

 

Cross-Functional Communication and Leadership

• Translated laboratory results into consumer-facing product claims to align technical evidence with product positioning and credibility.

• Coordinated with Distribution/Logistics, Sales, Marketing, Clinical, Creative Design, FDA/IEC consultants, suppliers, and international counterparts to align product documentation, packaging, compliance, launch readiness, and market understanding.

• Communicated with Sales representatives to further their understanding of new devices to present to hospitals.

• Presented component and prototype designs to Marketing and Clinical teams during design reviews, gathering feedback to align product development with user and market needs.

• Advised a team of Carnegie Mellon University Capstone Students to execute their project on the relationship between sample dimensions and material characteristics.

• Traveled to Shanghai to tour supplier facilities and collaborate with China manufacturing/development teams on manufacturing processes, materials, products, and process improvements.

• Represented EHOB at industry conferences including Wound, Ostomy, and Continence Education Expo, Advanced Textiles Expo, American Medical Device Summit, MD&M, and Usability Engineering/Human Factors Conference.

 

Documentation, SOPs and Training

• Active participant and owner of various SOPs, work instructions, and templates for Product Development processes in alignment with ISO 13485.

  • Authored and Released procedures/templates for Design Control, Design Reviews, Design Verification,  Prototype Logs

  • Drafted early-stage procedures and forms for Design Requirements, Design Outputs, Material Specifications, Safety Data Sheets, Product Drawings, Critial-To-Quality Document

  • Contributed/Reviewed procedures/templates for Design and Development File, Product Design Change Control, User Needs, Product Specification Log

• Co-developed and implemented a Packaging Label Database to improve Product Development, Quality, and Operations efficiency.​

 

Items worked on (PC=Product Change, EP=Exploratory Project): 

• BAM Pro/BAM Pro XL (Crete, EP) → Design Transfer, Nonprovisional Patents, PC R&D 

• BAM Air/BAM Air+/BAM Air LC (Fiji, Elba) → R&D, Design Verification, Design Transfer, Nonprovisional Patents, PC R&D, PC Verification 

• EHOB Air Pump, Pump Cart (Fiji) → R&D, Design Transfer, Nonprovisional Patents, PC R&D 

• Position Perfect ComfortTop (Sicily) → R&D, Design Verification, Design Transfer

• High Altitude WAFFLE Cushions (Keys) → R&D, Design Verification, Design Transfer 

• Position Perfect Small Covered Wedge (Tybee) → PC R&D, PC Design Verification, PC Design Transfer, PC2 R&D, PC2 DV 

• BAM Sheet Standard/Short/XL (Tanna) → PC Ideation, PC Design Verification, PC Design Transfer

• TruVue Air Heel Protector (Malta) → Design Validation, Nonprovisional Patents, PC R&D, PC Design Verification