Cristina Avato
Boston
Summary
Results-driven Biomedical Engineer with over 3 years of experience in developing mechanical test methods and validating drug delivery systems in regulated environments. Expertise in protocol development, technical documentation, and ensuring ISO/FDA compliance. Proficient in utilizing universal testing platforms and statistical analysis to support product qualification and enhance client deliverables.
Overview
3
3
years of professional experience
Work History
JUNIOR DCS/DDS MECHANICAL SCIENTIST
Stevanato Group
Boston
01.2024 - Current
- Developed and validated 15+ mechanical test methods for drug delivery and containment systems, leveraging ISO standards as foundational frameworks while defining custom performance criteria to support product-specific functional requirements.
- Designed and executed verification protocols to assess functional performance, dimensional tolerances, and structural integrity of components.
- Defined acceptance criteria, authored validation protocols, and executed statistical analysis to ensure method robustness, repeatability, and compliance within the Quality Management System.
- Ensured compliance with ISO 13485 and FDA 21 CFR Part 820 within the QMS.
- Authored validation documentation including protocols, reports, and traceability records supporting design verification and regulatory submissions.
- Collaborated cross-functionally with engineering and quality teams to support design reviews and risk assessments.
BIOMECHANIST
Rockland Peak Performance
Paramus
05.2023 - 01.2024
- Conducted motion capture sessions using Qualisys and Visual3D to assess joint kinematics and force distribution.
- Analyzed mechanical inefficiencies to inform strategies for enhancing performance and durability.
- Presented motion-capture results to players and coaches, facilitating development of targeted strength, mobility, and pitching programs.
RESEARCH & DEVELOPMENT INTERN
Resilience, Inc.
Tampa
09.2022 - 03.2023
- Researched pressure dynamics, flow rate optimization, and material selection, enhancing product efficiency and manufacturability.
- Created CAD models in SolidWorks to support prototype design iterations.
- Contributed to cross-functional design discussions and feasibility evaluations, supporting effective project outcomes.
Education
Bachelor of Science - Biomedical Engineering
Rutgers University
New Brunswick, NJ05-2023
Skills
- Test method validation
- Protocol authoring
- SOP development and revision
- Regulatory compliance
- Data collection and analysis
- Data visualization
- MATLAB programming
- Minitab statistical analysis
- SolidWorks design
- Onshape modeling
- Universal testing machines operation
- testXpert software
- Force plate measurements
- Biomechanics performance analysis
- Motion capture technology
- Risk mitigation
- Root cause investigation
- Microsoft Office Suite proficiency
Timeline
JUNIOR DCS/DDS MECHANICAL SCIENTIST
Stevanato Group
01.2024 - Current
BIOMECHANIST
Rockland Peak Performance
05.2023 - 01.2024
RESEARCH & DEVELOPMENT INTERN
Resilience, Inc.
09.2022 - 03.2023
Bachelor of Science - Biomedical Engineering
Rutgers University