999 Main Street • Any Town, NY 99999 • 999-999-9999 • firstname.lastname@example.org
- than 5 years of experience in areas of quality assurance, manufacturing and clinical engineering
- Knowledge of FDA design control guidelines, 510(K) Pre-market notifications, IDE submissions
- Strong knowledge of FDA 21CFR part 820, ISO 13485, ISO 14971, EU medical device directives.
- Excellent experience in engineering fundamentals, project management and medical device technology
- Formally trained on CAPA, FMEA and ISO13485 auditing at Central Connecticut State University
- Understanding of engineering tools like Six Sigma, Design of Experiment and statistical process control
- Extensive knowledge of human physiology, surgical procedures and operating room environment
- Self-motivated, organized, proficient team player with excellent communication and interpersonal skills
ABC Inc. Any Town, NY (Mar 2007 till Present)
- Product development, installation, and servicing of complex optical-based electro-mechanical instrumentation, used for cell-based life science applications.
- Alignment of optical and mechanical systems used for imaging and laser-based manipulations.
- Assistance with training Service Personnel covering U.S. and overseas territories and providing instrumentation support for Field Applications Support.
- Coordinated with Customer Service, Sales and multi-disciplinary development teams to support in the validation of new biological applications and cell counting.
XYZ Corp, Any Town, NY (Aug 2005 to Aug 2006)
- Worked on periodic maintenance, identification and rectification of faults occurring in the equipment.
- Grasped concepts on imaging modalities like MRI, fMRI, CT, SPECT, PET.
- Learned basics of labs like Hematology, Rheumatology, Endoscopy, and Blood Banks amongst others.
- Witnessed 8 different “State of the Art” Operation Theatres and also the surgeries conducted in each.
- Assisted the various surgeons in handling of biomedical equipments during their .
- Researched on PACS, a system being used there which works in collaboration with the US army defense.
- Assisted the major working departments like Artificial Kidney Dialysis, Radiation Oncology, Ultrasound, Mammography, and Central Sterile Supply Department.
- Gained knowledge on major oncology equipments like Linear Accelerator, Simulator, Gamma Knife, High Dose rate Machines based on the principle of Brach therapy.
- Grasped concepts of different types of lasers like CO2, Nd Yag and their use.
Biomedical Technician Internship
BCD Inc, Any Town, NY (Nov 2003 to Jul 2004)
- Provided preventive maintenance service on biomedical equipment.
- Conducted electrical safety test.
- Performed routine checks and troubleshot medical equipment.
- Accurately documented work orders, repairs and preventative maintenance records.
Master of Biomedical Engineering (2006) University of New York
Bachelor of Biomedical Engineering (2001) New York University, NY
- Heart Rate Monitor Design and Prototype:
- Developed a prototype of instantaneous heart rate monitor based on ECG R wave detection.
- Developed design specifications, circuit schematics, selected electronic components according to specification and fabricated a working prototype
tools: MATLAB, PRO-E, Design-Expert, Minitab
Medical Devices: Anesthesia workstations, Patient monitors, Ventilators, Sterilizers, ECG machines, Flexible and rigid scopes, Oximeters, Defibrillators, Surgical microscopes, Blood gas analyzers, Endoscopy camera systems etc.
- Certified on Draeger medical Narkomed anesthesia machines
- Certified on CAPA, FMEA and ISO 13485 Auditing at Central New York University