Ismael Joaquin
Carlstadt,NJ
Summary
Accomplished engineering professional with extensive experience in system verification, validation, and quality assurance for electromechanical and software-integrated devices. Skilled at leading cross-functional teams and translating user needs into precise requirements, developing validation strategies, and executing end-to-end testing for hardware, software, and integrated systems. Demonstrated expertise in ensuring compliance with FDA, ISO, and IEC standards, risk management, root cause analysis, CAPA resolution, and continuous process improvement. Proficient in QA methodologies, documentation, system interface testing, and implementing quality interventions that enhance product safety and reliability. Recognized for delivering reliable, compliant, and high-quality engineering solutions in both leadership and technical capacities, with strong foundation in biomedical engineering principles and hands-on experience with complex devices.
Overview
9
9
years of professional experience
1
1
Certification
Work History
System Engineer II
Vantage Medtech
Lyndhurst, NJ
10.2024 - Current
- Oversee system validation and design verification for Class II/III electromechanical devices in compliance with FDA 21 CFR Part 11, ISO 13485, and IEC 62304. Interface with clients to gather user requirements, develop high-level specifications, and manage anomalies across Development and Production environments. Conduct risk management activities including FMEA development and verification of mitigations. Execute verification and validation of system interfaces and workflows, maintaining adherence to project schedules.
- Executed 100+ verification protocols validating 400+ system and software requirements with full traceability through SDLC.
- Produced validation deliverables including User Requirements Specifications, Functional Specifications, Validation Plans, Traceability Matrices, and Summary Reports.
- Implemented risk management per ISO 14971 and verify mitigation effectiveness through testing and documentation.
- Investigated and resolved 100+ deviations and anomalies identifying root causes and validating corresponding software builds.
- Completed all verification and validation projects on schedule, ensuring consistent compliance with quality standards.
System Engineer I
Vantage Medtech
Moonachie, NJ
03.2022 - 10.2024
- Conducted test verification and requirement remediation for Class II/III electromechanical devices. Supported development of project FMEAs and Hazard Analyses. Performed verification and validation of system interfaces and workflows while maintaining adherence to project timelines.
- Executed verification and validation activities achieving 100% on-time completion across all assigned projects.
- Contributed to formation of FMEAs and Hazard Analyses to identify and mitigate system risks.
- Remediated system requirements to maintain compliance with FDA, ISO, and IEC standards.
Quality Assurance Engineer
Horiba Scientific
Piscataway, NJ
12.2018 - 03.2022
- Led CAPA investigations and root cause analyses for hardware and software issues, ensuring sustainable quality resolutions. Logged, tracked, and supported timely closure of NCs and deviations while maintaining audit-ready records. Reviewed and updated SOPs, test procedures, and QA checklists to enhance compliance and usability. Performed quality inspections and exploratory testing to identify defects and improve system performance.
- Achieved 98% production compliance rate through rigorous inspection and testing processes.
- Reduced ongoing service issues by 80% for high-demand product.
- Strengthened quality system documentation by reviewing and updating SOPs, test procedures, and QA checklists.
- Resolved CAPAs and deviations efficiently, ensuring long-term corrective actions and audit readiness.
Biomedical Technician (Intern)
New York Presbyterian Hospital
Manhattan, NY
06.2017 - 02.2018
- Performed preventive maintenance and electrical safety checks on medical devices, including infusion pumps and defibrillators. Maintained inventory and calibration records of test equipment using live Excel spreadsheets.
- Ensured operational safety and compliance of critical medical equipment through routine inspections.
- Tracked and updated equipment inventory and calibration data accurately to support maintenance workflows.
Education
Bachelor of Science - Biomedical Engineering (Biomechanics)
New Jersey Institute of Technology
Newark, NJ05-2018
Skills
- Technologies: SAP, Salesforce, Microsoft Excel, PowerPoint, Polarion, ALM, Jira, Confluence, JAMA, Oscilloscope, Multimeter, Wireshark, Manometer, Microsoft Teams,
- Technical Skills: Test Planning, Test Execution, Test Documentation, Verification & Validation Testing, CAPA, Continuous Improvement, Electromechanical & Software-Hardware Integration Testing, End-to-End Testing, Traceability, Defect Tracking
- Methodologies: Agile, Waterfall, Blackbox Testing, Exploratory Testing, Root Cause Analysis, 5 Whys, Deviation Investigation, CAPA, Root Cause Analysis, Regulated Quality Systems
Certification
Certification: Engineering In Training (EIT)
Languages
Spanish
Native or Bilingual
English
Native or Bilingual
Timeline
System Engineer II
Vantage Medtech
10.2024 - Current
System Engineer I
Vantage Medtech
03.2022 - 10.2024
Quality Assurance Engineer
Horiba Scientific
12.2018 - 03.2022
Biomedical Technician (Intern)
New York Presbyterian Hospital
06.2017 - 02.2018
Bachelor of Science - Biomedical Engineering (Biomechanics)
New Jersey Institute of Technology