Job Overview

Hoxworth Blood Center (HBC), University of Cincinnati, was founded in 1938 and serves more than 30 hospitals in 18 counties in Southwestern Ohio, Northern Kentucky, and Southeastern Indiana. Annually, Hoxworth collects more than 100,000 units of blood from local donors to help save the lives of patients in area hospitals. Hoxworth Blood Center: Saving Lives Close to Home.   HBC is located within the College of Medicine and is the only Regional Blood Center owned and operated by a University in United States.

HBC is recruiting for Manager, Biomedical Engineering, to manage the daily operations of the Biomedical Specialist team, and ensure strict compliance with product quality assurance, equipment and procedural standards, health and safety protocols. Experience in daily production of cleanroom environments, as well as interviewing, selection, hiring, and training of new employees with knowledge in cleanroom environment and regulatory framework in accordance with cGMP, FDA, and ISO regulations pertinent to the environmental control in ISO7/8 facilities is crucial.

The department supports all operational units within the organization. It ensures effective qualification, use, maintenance, calibration, and repair of medical equipment used in the provision of blood, blood components, tissues, and derivatives in accordance with safety standards and regulatory requirements. The manager implements strategic planning initiatives with experience and working knowledge of metrology, facilities maintenance, and ISO 8655 and/or 17025. Manages cross functional activities that support the interdepartmental communications, productivity, and quality between various operating units. Ensures high quality customer service and successful delivery of outputs. Facilitates qualification and maintenance of all materials/supplies for efficient support to operations. Promotes training, leadership, and staff growth and development.
 

Essential Functions

• Execute the strategic plan of the division, provide leadership to help manage and grow the department and team, and execute core operations in accordance with federal, state, and local laws, regulations, and standards.
• Ensure effective use, maintenance, calibration, and repair of medical equipment in accordance with safety standards, regulatory requirements.
• Ensure methods in metrology are appropriately implemented and standards are maintained according to ASTM requirements.
• Create, implement, and maintain policies and procedures for the department.
• Write technical documents for standard operating procedures (SOP), training, validations, and requalification documents.
• Ensure timely project delivery, proper equipment handling, and consistency of operations.
• Assist with planning the department budget with the Division Director, Core Operations.
• Manage training and education of all employees in the department. Train staff on new innovations, technology, equipment, software, and services. Provide technical assistance and instruction to staff regarding equipment operation and maintenance.
• Assist with the management of departmental contracts, and ensure all benefits related to such contracts are optimized.
• Manage interdepartmental communication, productivity, and quality between and among all operational departments.
• Support Hoxworth Blood Center’s safety, cGMP, and Quality Plan in coordination with the Division Director, Quality and Regulatory Affairs.
• Support and promote all aspects of our commitment to inclusion and core values.
• Provide direct and/or indirect supervision to exempt and non-exempt staff (i.e., hiring/firing, performance evaluations, disciplinary action, approve time off, etc.).
• Perform related duties based on departmental need. This job description may be changed at any time.

Required Education

Bachelor's Degree in Biomedical Engineering, healthcare, physical or biological sciences, or applicable field

Nine (9) years of relevant work experience and/or other specialized training can be used in lieu of education requirement.

Required Experience

Five (5) years of relevant work experience and/or other specialized training in the fields of equipment and instrumentation management, computer and software information systems, blood banking, biotherapies, transfusion medicine, or allied industries

Additional Qualifications Considered

• One (1) year of direct supervisory experience managing employees, teams, and assets is preferred
• Master’s Degree preferred
• MT/MLS (ASCP) certification preferred
• Working knowledge of computer software, metrology, inventory control, facilities maintenance, and ISO 8655 and/or 17025 experience highly desired
• Sufficient understanding of regulatory aspects in blood banking, biotherapies, and customer service.
• Strong technical and operational management experience.
• Proven track-record for implementing strategies that enhance productivity.
• Strong decision making and relationship management skills.
• Proven ability to build, sustain, and influence relationships at all levels of an organization.
• Exceptional communication and interpersonal skills with the ability to invoke change.
• Thrive in a corporate culture that expects excellence and innovation.
• Solution-oriented and makes sound decisions quickly, given tight timeframes.
• Excellent time/effort prioritization skills in an environment where numerous new demands will constantly arise.

Physical Requirements/Work Environment