Ismael Joaquin
Carlstadt,NJ
Summary
Detail-oriented Systems Engineer with a strong foundation in quality assurance, device requirement development, and medical device testing. Experienced in leading protocol design and validation for software and hardware components in regulated environments. Known for fostering team collaboration, precision in execution, and a commitment to continuous improvement.
Overview
9
9
years of professional experience
1
1
Certification
Work History
System Engineer
Vantage Medtech
03.2022 - Current
- Led the development of over 200 device requirements across multiple projects, aligning with customer needs and FDA regulatory standards
- Designed and executed comprehensive validation protocols for software and hardware systems, reducing time-to-verification by 10%.
- Conducted regression and risk analysis testing to ensure compliance with ISO 13485 and device performance after software updates.
- Conducted regression tests to validate product updates and enhancements, ensuring all improvements adhered to safety and quality requirements without introducing new risks.
- Collaborated in the design and ongoing maintenance of risk and hazard analysis
- Aided in the submission, validation, and verification of a medical device, ensuring regulatory compliance and a smooth pathway to market approval.
Quality Assurance Engineer
Horiba Scientific
12.2018 - 03.2022
- Conducted QA inspections for spectrometers, cameras, and accessories, achieving 98% accuracy.
- Improved inspection throughput by 20% to meet critical end-of-month quotas.
- Maintaining of Complaint Sheets and Corrective Action Reports (CARs).
- Managed non-conforming material, coordinated with vendors for replacements, and maintained detailed complaint and corrective action report
Biomedical Technician
New York Presbyterian Medical Center
06.2017 - 02.2018
- Performed preventative maintenance, electrical safety inspections, and troubleshooting on medical devices such as infusion pumps and defibrillators.
- Accurately documented all repair and service procedures in accordance with hospital protocols and regulatory requirements over a 6 month Period.
Cashier
BJ’s
07.2016 - 10.2016
- Restocked and organized merchandise in front lanes.
- Answered questions about store policies and addressed customer concerns.
- Operated cash register for cash, check, and credit card transactions with excellent accuracy levels at 99%.
Education
Bachelor of Science - Biomedical Engineering
New Jersey Institute of Technology
Newark, NJ05.2018
Skills
- System Integration Testing
- Test Case development
- Regression Testing
- Ad-hoc testing
- Validation Testing
- Defect tracking
- Team Collaboration
- Attention to Detail
- Quality Management Systems
- Risk Analysis
- Jira
- Polarion
- Microsoft Office
- Attention to Detail
Accomplishments
- Achieved Eagle Scout the Highest Rank in Boy Scouts of America
Certification
- Engineer in Training (EIT)
- ISTQB Foundational Level (Pending)
Languages
Spanish
Native or Bilingual
English
Native or Bilingual
Timeline
System Engineer
Vantage Medtech
03.2022 - Current
Quality Assurance Engineer
Horiba Scientific
12.2018 - 03.2022
Biomedical Technician
New York Presbyterian Medical Center
06.2017 - 02.2018
Cashier
BJ’s
07.2016 - 10.2016
Bachelor of Science - Biomedical Engineering
New Jersey Institute of Technology
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