Medical Device Manufacturing

Christopher Honigsberg

*** ** **** ******, ***. *, Oklahoma City, Oklahoma 73103

405-***-****, **********************@*****.***

Objective

To obtain a challenging and rewarding career position utilizing substantial work experience in safety operations for a radioactive medical device manufacturer, a strong science education, and outstanding organizational, interpersonal, and leadership skills.

Experience

Core Oncology, 2000-2011 Oklahoma City, Oklahoma

Radiation Safety Officer, 2008-2011

• Establish administrative controls relating to the organization, management, procedures, material control, and management review necessary to ensure safe operation of a medical device manufacturing facility

• Exercise independent authority to stop any and all operations deemed to be unsafe

• Lead the development and implementation of safety initiatives for routine operations and projects to ensure that radioactive exposure to employees and contractors is maintained as low as reasonably achievable (ALARA)

• Responsible for the management of all aspects of the company’s safety program including radiation safety and protection, licensing and permits, health hazard assessments, employee radiation exposures, contamination control, routine inspections, area surveys, fire safety, adverse weather events, hazardous chemical safety, first aid, CPR, and general lab safety

• Maintain radioactive material possession activities including isotope possession limits, sealed sources, returned product, radioactive waste, and in-house decay

• Responsible for the evaluation, approval, and maintenance of customer radioactive material licenses

• Consult with federal, state, and local authorities with respect to all applicable rules and regulations including the Occupational Safety and Health Administration, the Nuclear Regulatory Commission, the Oklahoma Department of Environmental Quality, the Environmental Protection Agency, the Department of Transportation, and the Food and Drug Administration

• Consult with the Regulatory Affairs Manager to evaluate and ensure compliance with all applicable regulatory requirements including the Food and Drug Administration’s Quality System Requirement, ISO 13485, ISO 9001, ISO 14001, and Canadian Medical Device Regulations

• Consult with distributors to ensure compliance with international law and licensing regarding the import, distribution, and sale of brachytherapy sources for the country of South Africa

• Responsible for the facilities maintenance program including the HVAC and HEGA systems, electrical, mechanical, and grounds and all associated permits and inspections

• Continue to support the manufacturing department by providing guidance and training, maintaining inventory requirements, ordering raw materials required for manufacture, and working with the plant manager to utilize lean manufacturing practices

• Directly manage a staff of three and indirectly supervise a staff of thirty

Radiation Management Advisory Council Member, 2010-Present

• Appointed to a three year term by Governor Brad Henry

• The council serves as the initial rulemaking body for the Land Protection Division of the Oklahoma Department of Environmental Quality and operates under the authority of the Oklahoma Radiation Management Act

• The council holds public hearings, reviews radiation management issues, and provides expertise about various radiation management issues

• All radiation management rules and regulations must first be reviewed and approved by the council before being recommended to the Environmental Quality Board, State Legislature, and the Governor for final approval

Manufacturing Supervisor, 2007-2011

• Responsible for the operation and manufacture of I-125 brachytherapy sources for over three hundred customers in the United States, Canada, and South Africa

• Utilize lean manufacturing and Kaizen principles to establish and maintain a target inventory used to accurately forecast sales, reduce the manufacture of excess brachytherapy sources, decrease the number of manufacturing runs, and significantly reduce the amount of raw materials purchased

• Work directly with the Radiation Safety Officer to evaluate and improve unsafe work practices and radiation exposures of manufacturing personnel as well the general lab safety of the facility

• Responsible for the order, receipt, use, and decay of multiple curies of radioactive material as a licensed authorized user

• Coordinate activities of the engineering department to ensure manufacturing equipment is properly maintained and operating to meet customer demands and fulfill company objectives

• Lead projects requiring the combined efforts of the manufacturing and engineering departments to improve automated equipment and support further product development

• Consult with executive management and marketing staff to determine engineering feasibility and cost effectiveness for new and existing products and processes

• Develop a manufacturing plan and establish procedures for maintaining high standards of manufacturing operations to ensure that products conform to established customer and company quality standards

• Develop and maintain informational systems using statistical processes to track and report manufacturing efficiencies and effectiveness

• Review production and operating reports and resolve manufacturing and maintenance problems to ensure minimal cost and prevent operational delays

• Directly manage a staff of six

Production Technician II, 2000-2007

• Proficient with the use of highly specialized automated equipment utilizing lasers, small moving parts, and fiber optic sensors

• Directly responsible for ordering, stocking, and maintaining raw materials and supplies for both the manufacturing department and the facility

• Responsible for review of established systems for evaluating and changing written documentation and procedural practices within the manufacturing department

• Responsible for the instruction of all new employees for the safe use of radioactive material at each stage of the manufacturing process

• Consult with the Radiation Safety Officer and plant manager to improve compliance for both manufacturing and radiation safety

• Assist management with studies for the improvement of the manufacturing process and new product development

• Provide training and leadership to fellow employees

• Display willingness and initiative to take on new tasks and assignments

Education University of Oklahoma College of Arts and Sciences, 1988-1994 Norman, Oklahoma

• Bachelor of Science in Zoology

• Bachelor of Arts in English

• Minor in Biological Anthropology

Leadership and Honors

• President’s Leadership Class

• David A. Burr Outstanding President’s Leadership Class Alumni Scholarship Award

• Campus Activities Council, Vice Chairman

• University of Oklahoma Community Service, Chairman

• University of Oklahoma-Ritsumeikan University Intercultural Exchange Program, Chairman

• Sigma Nu Fraternity, President

• Big Man on Campus

Professional Skills and Abilities

• Proficiency with Microsoft Word, Excel, and SharePoint

• Certified Radiation Safety Officer Training Course

• Oklahoma Safety Council Continuing Education courses for OSHA regulations include General Industry Standards, Safety Inspections, and the Master of Compliance Series

• Certified in CPR and First Aid

• Professional image with outstanding oral and written communication skills enable excellent communication at all organizational levels

References Available upon request

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