AF Clothing & Textile Program Office Liaison at Natick Soldier SystemsCenter

Provide systems engineering support to the US Army's efforts to reduce the individual soldier/small unit physical burden as part of the Technology Enabled Capability Demonstration (TECD) 2A team at the US Army Natick Soldier Research Developement and Engineering Center

As a member of the program leadership team (Program Manager, Lead System Designer, and Lead Program Integrator) responsible for the development, integration, and release of a new class II medical device that processes cord blood for cyro-freezing. Duties include: driving New Product Introduction program execution for the device. Develops the Integrated Program Plan and ensures that the necessary resources are applied and delivering to plan. Work with a small cross-functional team to ensure product manufacturability, serviceability, safety and quality. The development and tracking of detailed schedules for the two Contract Manufacturing Organizations (CMOs) responsible for the hardware and disposable that comprises the system as well as an integrated schedule for complete program tracking by team members and upper management. Responsible for development and implementation of the Device History File (DHF); As MyWorkshop Junior Librarian in processing (upload/approval) of all required program and QMS documentation from GEHC and the CMOs into the GEHC document control system (MyWorkshop) and its associated electronic New Product Introduction (eNPI) system. Manage the DOORS program database and advise members of the program Core Team on program and system engineering methodologies and procedures.

Senior Systems Engineer, IDS, Systems Architecture, Design & Integration Directorate (SADID) As a member of the ICWG team, coordinated the definition and capture of Zumwalt interface requirements, and defined and updated associated processes. Reviewed, tracked, processed and implemented System Trouble Reports (STR) using iTracker forms and software for interface requirements for the Navy’s new Zumwalt class destroyer. Reviewed, followed-up and chose assignees for open Interface requirements STRs. Conducted ICWG and working meetings to facilitate the definition and capture process, as well as the update process in support of the System RCRB. Primary responsibility in several mission thread areas. Prepared for and chaired the weekly ICWG meeting. Preparation included two weekly pre-ICWG meetings to coordinate and process open STRs. Conducted weekly assigned mission thread telecon meeting to coordinate and process open STRs. Used other collaboration methods, such as email, Sametime and/or telephone, to adjudicate issues. Created DOORS change proposals (CP) to implement Interface Requirements Logical List (IRLL) interface requirement changes, additions, and deletes from approved STRs. Verified DOORS CPs created by other team members. Used Rational Rose and Clearcase modeling software to create, delete, and change interface objects to implement STR approved proposals in the Zumwalt Integrated Equipment Model (IEM) from approved STRs.

Performed systems engineering tasks requiring the application of standard system engineering techniques, procedures and criteria. Worked with Marketing to define technology needs and helped define and plan associated R&D programs. Developed product requirements and system specifications. Managed/Coordinated systems Verification and Validation activities and Hazard - Analysis Processes. Developed medical instruments over a full-product lifecycle in a regulated environment (21 CFR, IEC 60601, ISO 13485, and ISO 14971). Defined product requirements and led product verification and validation efforts, development and testing of biological sensor equipment using DOORS Requirement Management Software Knowledge. DOORS Administrator, Project File administrator and R&D Change Control Board chairmen.

Perform systems engineering tasks requiring the application of standard techniques, procedures and criteria in carrying out related engineering tasks. Work with Marketing to define technology needs and help define and plan associated R&D programs. Develop product requirements and system specifications for advanced instrument systems. Manage/Coordinate systems Verification and Validation activities, Hazard - Analysis Process, and adhere to R&D and company ISO procedures and FDA standards. Provide expertise in engineering/scientific disciplines while understanding and assisting in the resolution of complex multidiscipline problems of design challenges. Develop medical instruments over a full-product lifecycle in an FDA regulated environment. Define product requirements and lead product verification efforts, development and testing of biological sensor equipment using DOORS Requirement Management Software Knowledge.

Perform investigational and validation testing and various engineering functions in support of the company’s research and development efforts for ablation catheter manufacture. Use/Maintain Lab Notebooks, author various reports and rationale for testing. Perform testing; write test procedures, Risk Analysis, FMEAs, and summary reports. Interface with company vendors. Apply various EN, ANSI/AAMI, and FDA requirements environment (21 CFR, IEC 60601, ISO 13485) to testing and validation. Write and process initial release and follow-on Engineering Change Orders and specifications. Process and Document Medical equipment from design to commercial release.

Managed, supervised, trained, directed, and provided engineering support to a 21-26-member team in four areas: Final Test; Computer Test, Software Duplication, and Systems Options; Board Test, and Repair Depot. Controlled/managed manning and budgets. Established and Reported on Manpower Standards and Labor usage. Research, investigate and report Production, Install and Depot, First-Pass-Yields and Trends and resolutions. Member of the CAPA, MRB and internal/external audit teams. “Model” training program. Complete Device History Records in accordance with existing FDA and ISO requirements (21 CFR, IEC 60601, ISO 13485) and company guidelines for Class II Medical Devices. Write Engineering Change Orders (ECO) and process/coordinate approvals. ECO Board member… Approve/Recommend changes to ECOs

Production ManagerManage, supervise, train, direct, and provide engineering support to a 21-26-member team. Support company efforts in four areas: Final Test; Computer Test, Software Duplication, and Systems Options; Board Test, and Repair Depot. Controlled/managed manning and budgets. Establish and Report on Manpower Standards and Labor usage. Research and Report Production, Install and Depot First-Pass-Yields and Trends. Hire, promote and fire employees, as appropriate. The Repair Depot includes all aspects of the company’s product lines, old and new. Inspect, test, document, and certify, PCBs, sub-assemblies, systems, computers, and computer peripherals. “Model” training program. Complete Device History Records in accordance with existing FDA and ISO requirements and company guidelines for Class II Medical Devices. Write Engineering Change Orders (ECO) and process/coordinate approvals. ECO Board member… Approve/Recommend changes to ECOs.

Pope AFB, NC.1992 – 1995 Headquarters Ground Equipment (Program) Manager Directed up-grades, replacements, maintenance, etc., for 180 Communications Weapons and Tactical Weather Systems at ten sites across the US. Received Meritorious Service Award for Outstanding Performance.Soesterberg AB, The Netherlands 1989 – 1992Communications Maintenance Superintendent Manage seven maintenance shops: Telephone - Inside and Outside Plant, Cryptological, Radio Maintenance, Facsimile, Public Address, and Security Systems. Supervise, train, direct the Support Staff (Administration, Job Control, Material Control (supply), Quality Control, and Training/Technical publications). Langley AFB, VA. 1987 – 1989Command Communications Systems Maintenance Inspector (HQ IG team) Search and investigate incidents of non-compliance with management and technical directives for 13 active duty and 62 reserve installations.Received Meritorious Service Award for Outstanding Performance