Brandon Kassouf
St. Petersburg,FL
Summary
Quality engineer with a strong record of executing product launches ahead of schedule and improving product quality through risk-based decision-making. Experienced in CAPA, nonconformance investigations, design controls, FMEA, V&V, and audit support within an ISO 13485-based QMS. Adept at partnering cross-functionally to resolve quality issues, strengthen compliance, and bring clinically differentiated medical devices to market.
Overview
3
3
years of professional experience
Work History
Quality Engineer II
CONMED
Largo, USA
02.2025 - Current
- Lead quality assurance and project management for product launches and design changes, ensuring compliance with an ISO 13485:2016-based QMS and global regulatory requirements, including FDA 21 CFR Part 820 and EU MDR 2017/745
- Investigate design- and use-related failure modes from feasibility testing, surgeon evaluation labs, and post-market surveillance; update risk management documentation, including DFMEAs, and partner with R&D to implement design mitigations that reduce residual risk
- Own CAPA investigations, support root cause analysis, and implement corrections to address quality issues
- Support external audits by the FDA, BSI Group (EU Notified Body), and Brazilian regulatory authorities by scribing, coordinating cross-functional responses, and fulfilling auditor requests promptly
- Coordinate cross-functional teams on project timelines, risk mitigation, and V&V strategy (protocol planning, traceability, and evidence readiness); train new project managers on change control
R&D Engineer I
CONMED
Largo, USA
02.2024 - 02.2025
- Supported remediation efforts by completing adoption reports for 310 Class Ir devices, reviewing ISO standards and FDA guidance, and scribing for a key audit to relay documentation requests and OFIs
- Drafting design control documents for design inputs, V&V testing, and risk management
- Designing verification tests compliant with ISO and ASTM standards to support new product development
- Leading cadaver labs with surgeons to gather VoC, identify potential risks, and inform design changes
Duke Master’s Student
Design in Healthcare 3 Project
Durham, USA
08.2023 - 12.2023
- Served as engineering lead and project manager for a team of 8 creating a new emergency airway device
- Designed CAD models and 3D printed prototypes to tackle the greatest technical risks
- Managed Gantt charts in MS Project to monitor deadlines, responsibilities, and the status of deliverables
- Met with consultants and industry experts to clarify validation requirements and development timelines
Manufacturing Engineering Intern
ROBLING MEDICAL
Youngsville, USA
05.2023 - 08.2023
- Conducted process validation testing and statistical analyses for process capability in Minitab
- Wrote product requirements and verification test protocols in accordance with relevant ISO standards
- Created CAD models and drawings in SolidWorks for fixtures needed to manufacture medical devices
- Employed Toyota’s 5S method to improve cleanroom efficiency and lower manufacturing costs
Education
Master of Engineering - Biomedical Engineering
Duke University
Durham, NC12-2023
Bachelor of Science - Biomedical Engineering
Georgia Institute of Technology
Atlanta, GA05-2022
Skills
- FDA 21 CFR Part 820
- ISO 13485
- ISO 14971
- EU MDR 2017/745
- Design controls
- Risk management
- FMEA
- Verification & validation
- Root cause analysis
- CAPA
- Nonconformance investigation
- Audit support
- Statistical analysis
- Minitab
Timeline
Quality Engineer II
CONMED
02.2025 - Current
R&D Engineer I
CONMED
02.2024 - 02.2025
Duke Master’s Student
Design in Healthcare 3 Project
08.2023 - 12.2023
Manufacturing Engineering Intern
ROBLING MEDICAL
05.2023 - 08.2023
Master of Engineering - Biomedical Engineering
Duke University
Bachelor of Science - Biomedical Engineering
Georgia Institute of Technology