Product Development and R&D

• 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 MSDS from suppliers

• Collaborated with patent lawyer to quantify and describe unique product features for trademarks and design/utility patents, having patent applications being filed faster than the company has ever filed before (at least 1 provisional or non-provisional a quarter since taking ownership of patent work, with yearly goal of 50 claims reached before Q2)

• Determined Translation Rationale, Design Inputs and Outputs, and Verification and Validation procedures

• Designed, Reviewed, and Maintained Records of Product and Quality Control 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 methods to improve the reliability of data gathering across products

• 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

• Developed test fixtures and custom equipment to improve repeatability, accuracy, and efficiency of product experiments.

• 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

• Played an active role in the development of an internal anthropometric database using employee volunteers as test subjects, enabling more realistic product testing and improving human-factor validation across prototypes.

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

 

Lab Equipment and Inter-departmental Process Optimization

• Diagnosed and resolved issues with lab equipment for Product Development and Quality​

• Improved product development’s policies, procedures, and documentation in risk management, design history management, test method development, training, patents…​

• 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. 

• Improved the quality of user needs by introducing a structured framework, enabling clearer design inputs and more effective validation studies.​

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

 

Quality and Risk Management

• Helped create and improve Risk Mitigation Protocol and Reports for released products

  • Was involved in IEC Risk Documentation for the EHOB Air Pump, but also developed DFMEAs and other risk documentation for non-electronic devices

• Determined root causes of post-product-release quality and in-field challenges, and established CAPAs to mitigate future problems

• Facilitated risk review meetings with Engineering team to align on primary product and process risks, mitigation strategies, and risk acceptability.

 

Labeling, Regulatory, and Database Management

• Determined ISO, IEC, SGS, and FDA-compliant UDI label symbols for user manual and product packaging

• Collaborated with the Creative Design team to create compliant UDI and box labels, in addition to product artwork and package inserts, for proper product shipment and use

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

• Automated uploading to Global Unique Device Identification Database by utilizing Python (bs4, pyautogui)

 

Cross-Functional Communication and Leadership

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

• Communicated with Distribution and Logistics teams to ensure products were being packaged and distributed as intended

• Communicated with IEC and FDA consultants to determine product compliance

• Communicated with international counterparts for all aspects of product development across multiple projects, including prototyping, documentation consistency, manufacturing, and quality control…

• 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.

• Represented the company at conferences, including: American Medical Device Summit (Chicago, IL 2024); Usability Engineering/Human Factors Conference (Boston, MA, 2025), MD&M (Minneapolis, MN, 2024)

 

Documentation, SOPs and Training

• Wrote Standard Operating Procedures and Work Instructions for Product Development to comply with ISO 13485

  • Was involved in writing Procedures for Design Control, Design Changes, Design Inputs, Design Outputs, Design History File, Design Verification

  • Was involved in writing Work Instructions for {INSERT}

  • Was involved in writing Templates for {INSERT}

• Optimized Product Development, Quality, and Operations efficiency through the co-development and implementation of a Packaging Label Database