Product Support Manager - Asensus Surgical - Durham, NC
(2018-05)
Created and built a Service Depot repair center from the ground up. Manages the intake of defective components from field returns, repairs or reconditions them using validated procedures and testing.
The Service
Depot team is a high performing engineering team that has saved the company $4.5M in inventory savings with a <1% return failure rate. Developed a prototype predictive maintenance modeling system using regression analysis as a continuous improvement and operational efficiency measure. Kicked off a cross-functional team to design and implement. Liaison between global R&D, manufacturing, quality assurance, regulatory, operations, and service departments. Maintains all service documentation for preventative maintenance, functional testing, software and firmware updates, electrical safety, and repair adhering to ISO 13485. Assists in creating and performing technical customer training and second-level technical support for servicing-related activities. Member of the Continuous Innovation Core team responsible for bringing new ideas and technologies to Asensus.
- Responsible for managing direct reports, driving daily activities, assigning projects, setting goals and direction, and providing training opportunities through the year. Manages project timelines, budgets, and resource allocation.
- Responsible for creating and maintaining service documents, training service personnel, design transfer, managing service depot projects from concept to production, and authoring and maintaining pFMEAs.
- Responsible for the repair of returned serviceable items related to applicable supporting products complying with manufacturing standards while expanding remote service repair centers global capabilities to support the business.
- Represents service for audits performed by the FDA and TUV by providing proper documentation and training records in compliance with 21 CFR and ISO 13485.
- Responsible for recruiting, hiring, onboarding, and training all direct reports.
- Responsible for overall quality and completion of team deliverables in alignment with corporate goals, organizational launch timelines, and regulatory requirements.
- Responsible for initiating, updating, and completing Engineering Change Orders for Field Service, Product Support, and Service Depot documentation and activities.
- Acts as a Field Service liaison for new product serviceability, existing product upgrades, recalls, sterilization, Regulatory compliance, and system/component packaging with Engineering.
- Responsible for creating and maintaining all product procedural documentation and servicing manuals following industry standards and Regulatory compliance for all service-related activities.
- Responsible for creating and implementing process flows from Engineering to the field for launch activities from documentation, training, inventory readiness and work order creation with tracking of activities progress to completion.
- Create and establish matrixes to measure product reliability and product recall/upgrade completions within instructed timelines.
- Perform internal/external auditing of field service reporting and documentation to maintain ISO 13485 and 21 CFR compliance standards.
Electrical Engineer III - Black & Veatch - Cary, NC
(2011-04 - 2017-10)
- Performed engineering calculations like arc flash, transformer sizing, cable duct sizing, and UPS sizing calculations.
- Drafted schematics, wiring diagrams, one line diagrams, and circuit routing for publication in specification documentation.
- Circuit routing team lead for largest project in the history of the Cary office.
- Performed research for equipment/component selection, and prepared equipment specifications.
- Reviewed vendor drawings for accuracy and completeness to ensure deliverables meet system and subsystem requirements and industry standards and codes.
- Interfaced with vendors and contract manufacturers to ensure deliverables are met in a timely manner and within budget.
- Led project update meetings and prioritized activities.
Electrical Engineer - InnerPulse, Inc. - Durham, NC
(2007-10 - 2011-01)
- Led electrical component design, analysis and testing for a Class 3 Implantable Medical Device meeting stringent medical design requirements.
- Interfaced with vendors and contract manufacturers to coordinate orders and builds.
- Designed and set-up experiments for microcircuit characterization using LabView and bench testing.
- Redesigned layout of microcircuit leading to a smaller device with increased patient accessibility.
- Designed and documented component PCB layout and the associated schematics for Burn-in, Life Testing, and other testing as required.
- Cheerfully worked across functional areas and with vendor teams to ensure project success.
Senior Product Engineer – Power Management - Intersil, Corp. - Durham, NC
Promoted to Senior Product Engineer with 1 year.
- Coordinated engineering activities during new product development including design verification, characterization, qualification, and release from concept to production.
- Supported manufacturing for released products including continuous yield improvements and other cost reduction activities.
- Led cross-functional teams and maintained schedules and budgets on multiple products while interfacing with other engineering disciplines and various levels of management.
- Awarded several service awards for performance and yield improvements. Helped improve yield on product family and saved Intersil over $1M by reducing overall test time.
