Biomedical Design Engineer with Regulatory Expertise

JENNIFER P. VANSANT

Lake Worth, Florida • 321-***-**** • ***************@******.*** • linkedin.com/in/jennifer- vansant-0a64227a

PROFESSIONAL SUMMARY

Biomedical Design Engineer with experience in medical device and drug delivery product development within FDA- EU and ISO-regulated environments. Proven ability in design controls, design verification, technical and statistical analysis, tolerance analysis, and root cause investigation. Experienced collaborating cross-functionally with quality, manufacturing, and regulatory teams to bring devices from concept through verification and launch. CORE SKILLS

Design & Development: Design controls, pharmacovigilance, design inputs/outputs, verification planning, target drug release, DOE, Characterization testing, IVPT, dissolution testing, adhesive testing, project management

Mechanical & Device Engineering: SolidWorks (Coursera), tolerance analysis, design feasibility

Technical Analysis: Statistical analysis, ANOVA, root cause analysis Risk Management: FMEA, ISO 14971, hazard analysis, risk controls Regulatory & Quality: 21 CFR Part 820, ISO 13485, EMA 2001/83/EC, GMP, GLP, GDP, CAPA, assisted with regulatory submissions

Software: SolidWorks (Coursera), Excel, GraphPad Prism, COMSOL, Salesforce-TrackWise, Benchling, Quartzy

PROFESSIONAL EXPERIENCE

Senior Scientist I – Research & Development Formulations Aveva Drug Delivery Systems (a Difgen Company) — Miramar, FL 2024 – Present

• Execute design and development of drug delivery devices in accordance with formal design controls and regulated design history file (DHF) requirements.

• Develop design inputs, specifications, and verification strategies supporting combination product development.

• Plan and execute characterization, feasibility, and design verification testing to evaluate performance and reliability.

• Perform technical analyses including statistical analysis, DOE, ANOVA, and tolerance analysis to support design decisions.

• Conduct root cause investigations for nonconformance and performance deviations using structured problem-solving tools.

• Apply working knowledge of solvent casting and material selection to evaluate manufacturability.

• Confirm analytical testing with analytical R&D to support verification of drug release and compatibility assessments.

• Author and maintain R&D documentation including design reports, test protocols, test reports, SOPs, using TrackWise.

• Participate in risk management activities including FMEA and hazard analysis in compliance with ISO 14971.

• Support regulatory submissions aligned with FDA and EU requirements.

• Provide technical guidance and informal mentoring to research associates and cross- functional team members.

Research Associate – Research & Development

Vivex Biologics — Miami, FL

2022 – 2024

• Supported design and development of biologic and medical device-related products under ISO 13485 and GLP environments.

• Planned and executed feasibility and characterization testing supporting early-stage design decisions.

• Applied DOE methodologies and statistical analysis to optimize product and process performance.

• Conducted root cause investigations for experimental deviations and process variability.

• Utilized Benchling software for controlled documentation, traceability, and data integrity.

• Generated verification-style reports summarizing test methods, acceptance criteria, results, and conclusions.

• Collaborated cross-functionally with quality, production, and R&D to support development timelines.

• Contributed to new product pipeline through feasibility assessments and technical recommendations.

• Kept inventory and ordered lab supplies on Quartzy software and internal purchasing system.

Graduate Research Assistant – Vascular Tissue Engineering Lab Florida Institute of Technology — Melbourne, FL

2019 – 2021

• Co-authored peer-reviewed publication: Carbon Monoxide Release from Ultrasound-Sensitive Microbubbles Improves Endothelial Cell Growth.

• Synthesized and characterized microbubbles, evaluating size distribution, stability, and shelf-life performance.

• Analyzed in vitro studies of endothelial cells controlling variables over progression of experimental design.

• Utilized engineering principles including diffusion modeling, biomaterial compatibility, and transport mechanisms.

• Generated figures, statistical analysis, and graphical data presentations for publications and posters.

• Authored grant proposal and peer reviewed research publication in biomedical journal. EDUCATION

Master of Science — Biomedical Engineering

Florida Institute of Technology, 2021

GPA: 3.3 / 4.0

Bachelor of Science — Biology

University of Rochester

GPA: 3.6 / 4.0 • Magna Cum Laude

PUBLICATIONS

VanSant, J.P. et al. Carbon Monoxide Release from Ultrasound-Sensitive Microbubbles Improves Endothelial Cell Growth. (Peer-reviewed journal publication)

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