SUMMARY:

• Experience with FDA audits for a 501K exempt Class 2 medical devices (Back room/Front room) regarding Healthcare
• Deep knowledge of SDLC, Jira, verification and validation with traceability from a project to start to finish
• Testing new systems in verification and validation to ensure that they meet all documented requirements per the product requirements as defined by product management
• Experience with Quality Management systems for medical devices; Marketing, Product requirements and traceability, software design documents, design history records, and design inputs and outputs
• Designing products to pass UL requirement testing for Fire and Healthcare systems
• Managing staff, schedules and resources
• Server and workstation setup and management/Computer hardware troubleshooting
• Technical writing & Proficiency in MS Office products (Word, Power Point, Excel, etc.)
• Drive for continuous improvement and quality control in the nurse call and fire industries
• Ability to work with engineering to make sure all tests are complete prior to any release of product
• Drive for accurate documentation controls
• Responsible for keeping systems for regression testing and maintaining them

PROFESSIONAL EXPERIENCE:

Confidential

Quality Control/ Team Leader/ Project Manager

RESPONSIBILITIES:

• Helped to develop a new Healthcare platform for patients and nurses in regards to hardware design and usability by doing various ‘voice of the customer’ meetings.
• Worked closely with supply chain as well as 3rd party manufacturers to ensure compliance in regards to qualified servers and work station computers
• Involved in the integration of third party digital phone systems and pagers with our nurse call systems for nurses to contact patients directly or immediately get notification of patient calls
• Very good Knowledge in SDLC, Jira and Validation with Traceability from starting to ending of the project.
• Worked with Usability team to understand ‘Best Practices’ as how to best assist hospital personnel and make their daily activities easier
• Provided technical support via e - mail, telephone and onsite visits
• Worked with marketing to develop product release materials & industry trade show presentations.
• Following the strict FDA requirements for quality assurance for our classified ‘Class B - 501K Exempt’ devices for patient notification within hospitals
• Utilized Quality Assurance processes to design, develop and test the Ascom suite of patient notification products to verify their adherence to strict FDA requirements
• Testing for IT related solutions such as wireless, servers, workstations as well as VoIP as well as troubleshooting any issues, using different network tools such as Wireshark
• Involved in FDA and ISO audits to ensure compliance
• Led CAPA on products and recorded all complaints in JIRA
• Led continuous Defect Review Board Meetings throughout programs within engineering
• Documentation control was done in Myworkshop (GE Healthcare) & Sharepoint (Ascom)
• Involved in reviewing, approving and executing verification and validation test procedures
• Involved in mentoring new hires in the Healthcare field

Confidential

Team Leader

RESPONSIBILITIES:

• Led a global team responsible for completing the development and subsequent maintenance of Nurse Call products called Telergy & Telligence that were part of the earlier EST acquisition of Dukane. GE Security decided to close Dukane’s Warrenville, IL location and only a few employees would relocate. Local engineers needed to take over the project.
• Worked with manufacturing, purchasing, order entry and marketing to ensure that products were successfully transferred to provide a seamless product availability to customers
• Worked with various teams to re-brand all products
• Training on MINITAB as well as DOORS
• Greenbelt certified

Confidential

Software Engineer

RESPONSIBILITIES:

• Led an international team of 7 people in the maintenance and development of the aforementioned FireWorks product. As part of this team I created designs, wrote code, managed schedules, budgets & personnel, wrote and executed test plans and mentored junior engineers.
• This team was responsible for the development of a product called the High Level Network Card. The HNLC would reside on the FireWorks network and receive its operating system and runtime applications over the network from a FireWorks PC at boot time. The HNLC allows a FireWorks PC to interface with EST Fire detection products without having to be within the 50 foot RS-232 cable length restriction. This product was developed in C and managed via PVCS.
• This team was responsible for porting the FireWorks product to the Windows platform. Changing OS (OS/2 to Windows), development language (C to VB/C++) and the database (DB2 to SQL Server) all at once required significant redesign and recoding. This project was managed via Visual SourceSafe.
• Provided technical support via e-mail, telephone and onsite visits.
• Worked with marketing to develop product release materials and industry trade show presentations.
• Interfaced with internal departments (mechanical, documentation and test) to manage all parts of the project and interfaced with other development teams to integrate their products into FireWorks.
• As part of a six person team, developed an OS/2 based Fire Alarm product called FireWorks through its entire life cycle from design to deployment. The product was a scalable system with PCs running on a token ring network. FireWorks interfaced with EST Fire detection products and 3rd party building control systems and presented the data to the user in a graphical representation allowing user interaction primarily through touchscreen. The project was developed in C using DB2 and managed via PVCS.

Confidential

Software Engineer

RESPONSIBILITIES:

• Responsible for leading a team that configured test labs for development testing for a manufacturing floor control system
• Developed data collection systems for simplifying shipping and receiving activities.