Todd Borowicz Email & Phone Number

Peoria, Az, Us

Minneapolis, Mn, Us

Responsible for managing all activities required to develop and deliver new medical device products or therapies for the treatment of neurological disorders.

Marlborough, Ma, Us

Responsible for activities related to research and development, including directing the activities of a multi-technical functional design team responsible for designing, developing, modifying and evaluating the mechanical and electrical design of external medical devices. Responsible for all hardware related activities throughout product lifecycle focused on remote patient management communicators and programmers• Lead a team which includes mechanical and electrical design, configuration management, and project management personnel in the achievement of organizational goals. Guide, coach, direct, and develop direct reports, and drive those practices throughout the organization.• Manage technical and resource challenges of new product development and sustaining efforts on products including first generation cellular communicator, first generation MICS devices, and programmer software releases and hardware maintenance activities. Identify, communicate, and manage all risks, and develop mitigation strategies to ensure a successful completion of all project deliverables.

Ensure that systems, processes, and staffing are suitably designed and implemented to maintain an effective/active quality system in support of the operational departments. Ensure product safety, reliability and quality through the effective use of quality planning, risk analysis, statistical methods and process controls during the design and manufacturing stages of the product. Ensure efficient compliance to all applicable regulations through the implementation of a robust quality system and through communication/reporting to regulatory authorities. Responsible for multiple factories including printed circuit board assembly, pulse generator device assembly, high voltage capacitor assembly and battery assembly areas• Manage a manufacturing quality engineering group responsible for 4 separate manufacturing factories in the establishment of quality monitoring activities and general project quality review. Manage daily manufacturing metrics and issues to ensure project meets the high standards required of a medical device.• Developed risk based yield monitoring process and established risk based issue monitoring matrix utilizing health risk assessment, detectability, and occurrence.• Manage a manufacturing CAPA group reaponsible for cross functional investigations to determine root cause, corrective action recommendations, and regulatory/compliance impact. This includes internal manufacturing issues as well as field trend issues.

Provide operational program management and technical leadership to employees who are responsible for planning, developing, and coordinating new product development projects. Ensures that project objectives are determined and met, logistics are effectively coordinated, and budgets are adhered to. Product experience included several generation of ICD development including first generation RF telemetry ICD• Responsible for managing the operational activities within the Advance Manufacturing, Test Engineering, Manufacturing (worldwide) and Supplier Development in support of new product development projects. Develop the project team detailed schedule and cross-functional interdependencies, and management activities to meet overall project timelines.• Contributes to the development and monitoring of project budget through regular analysis of cost and spending• Responsible for project risk management through creation of Risk Management Plan and coordinate Risk Register updates; consolidate Risk Registers to identify high level project risks

Provide Project direction related to the implementation and project development for electronic instructions, as well as ongoing instruction development used in the manufacturing of implantable medical devices. Implementation included several manufacturing sites worldwide

Coordinate group activities related to the support and facilitation of investigations and corrective actions related to manufacturing issues, and generate manufacturing metrics for engineering and executive level management. Responsibilities included multiple manufacturing factories including printed circuit board assembly and pacemaker/ICD device assembly

Dulles, Virginia, Us

Project Lead Engineer providing support to medium to high volume Circuit Card and Sub-Assembly production areas

Charlotte, North Carolina, Us

Provide overall quality support in developmental design-to-production environment for several production programs