Experiences
Senior Biomedical Engineer
Ensured quality and compliance of breast cancer detection devices by managing risk assessments (FMEA, Hazard Analysis) and maintaining regulatory documentation in alignment with ISO 13485 and FDA standards. Supported product validation, regulatory submissions, and process improvements to enhance reliability and performance.
Feb 2023 - Present
Product Design Engineer
Ensured the quality and reliability of diagnostic instruments by performing preventive maintenance, resolving technical issues, and adhering to regulatory and compliance standards. Developed and implemented quality assurance checklists to improve equipment performance. Managed customer complaints with detailed documentation and supported continuous improvement initiatives to maintain optimal functionality and compliance.
Sept 2021 - Feb 2023
Medical Device Developer
Ensured quality and compliance of a medical robot for automated breast biopsies by conducting design verification, validation, and risk analysis (DFMEA) in alignment with ISO 13485 and FDA standards. Developed technical documentation for regulatory submissions and collaborated with cross-functional teams to refine performance through iterative testing. Supported manufacturing efforts to maintain high-quality standards and scalability.
Sept 2022 - Sept 2023
Biomedical Engineer Intern
Ensured optimal performance and compliance of medical equipment through preventive maintenance, calibration, and adherence to regulatory standards and hospital policies. Accurately documented maintenance and repair activities in the equipment management system to ensure traceability and regulatory compliance. Participated in pre-purchase evaluations, providing input to align new equipment with clinical needs and safety requirements. Contributed to improving equipment management processes and maintaining a safe and efficient clinical environment.