MICHAEL KALABAT

WATERFORD, MI • (***) ***. **** • adgkod@r.postjobfree.com

MEDICAL DEVICE ENGINEERING PRODUCT DEVELOPMENT QUALITY ENGINEERING Highly driven and technically proficient Biomedical Engineering graduate committed to applying sound practices to move product developments from R&D through manufacturing and management of current devices quality system. Work cross- functionally with multiple project teams to ensure medical devices meet quality review guidelines, FDA standards, and other industry mandated regulations. Equally strong in supporting data-driven decision-making by completing highly complex mathematical calculations, modeling, and process/design failure analysis. Possess a strong intellectual curiosity in how things interrelate and work together along with a drive to produce revolutionary, patient-centered medical devices. Areas of Competence:

Device Research Device Validation FDA Regulations Technical & Data Analysis Problem Solving Quality Assurance Testing Design of Experiments Database Management Cross-Functional Teamwork Report Writing Prototyping Impact & Tissue Biomechanics Medical Imaging Resource Allocation Technical: MATLAB MS Office Suite Advanced Excel AutoCAD LS-Dyna EDUCATION

WAYNE STATE UNIVERSITY – Master of Science Biomedical Engineering GPA: 3.5/4.0 MICHIGAN STATE UNIVERSITY – Bachelor of Science Biosystems Engineering GPA: 3.4/4.0 Academic Projects:

Biomechanics Research on Vehicle Roll-Over Incidents: Researched current and future strategies and technologies to mitigate roll-over injuries utilizing MATLAB.

Design Mathematical Models using LS-DYNA to Simulate NOCSAE Test: Used 3D modeling to simulate drop tests on football helmets to monitor the brain’s reaction.

Capstone Research Project with Perrigo for Bachelor’s Degree: Prototyped ideas to reduce the amount of hazardous waste generated by the Nicotine lazing manufacturing process. Extracurricular: Stood as the Chaldean American Student Association Vice President; 2013-2017 PROFESSIONAL EXPERIENCE

BEAUMONT HOSPITAL 2018-2019

Clinical Engineer Intern

Achieved weekly failure analysis testing and FDA reporting on explants and sterile disposables to generate a robust complaint investigation follow-up report and track the failed device exchange process with multiple manufacturers. Devised and implemented methods/procedures for inspecting, testing, and evaluating products from an engineering perspective to determine the root-cause of the failure. Interfaced directly with internal and external departments to execute responsibilities as a part of the hospital’s continuous improvement effort.

• Pulled information from the FDA’s MAUDE database to assist in making device selection recommendations based on historical data of failure rates.

• Coordinated capital equipment issues with manufactures and the Biomedical team to review proposed solutions.

• Applied acute understanding of technical documents associated with medical devices to inform and support the training of medical professionals.

• Developing and Implementing new storage and cataloging system of medical devices to increase efficacy.

• Reviewed Hospital incident reports to assess root cause of medical device failures. K4 MEDICAL DENTAL CONSTRUCTION 2015-Present

Project Coordinator

Serve as a project coordinator for construction projects ranging in value from $50K to $2.5M. Oversee project management activities, including team leadership, client/owner communications, sub-contractor management, quality control, materials management, scheduling, scope development, and budgeting. Develop and implement corrective action plans when deviations from budgets and/or schedules become evident.

• Work closely with numerous construction teams, state agencies, local municipalities, outside consultants, and company clients during municipal safety inspections to achieve final acceptance of and obtain sign-off documentation.

• Created preliminary drafts in AutoCAD for site plans and building layouts used by engineers to create construction documents

• Bridge the understanding between construction trades for the placement of medical equipment and medical equipment connections to structures and/or service provided utilities.