Audio Engineer, Producer and Artist Management

Duties and Responsibilities consisted of the following:Maintained medical device master records(DMR) is Agile/SAP DatabaseDeveloped device verification plans, protocols and verification summary reports based on internal engineering requirements and external regulatory requirements. Ref: IEC 60601, ISO 13485Sourced and qualified OEM components for Central Patient Monitoring System (ICS)Engaged Design FMEA and MTBF activitiesLegacy ICS device supportFDA 510k submission supportPerformed hardware gap analysis between legacy systems and developmental systemsHardware engineering representative for the Central Patient Monitoring System cross functional team Designed and retrofitted custom components for

Designed plastic, sheet metal and machined components utilizing Solidworks and GD&T techniques •Evaluated and conducted peer design reviews utilizing Solidworks Simulation packages, (stress, form and fit)•Maintained device master records(DMR) in Agile/ SAP Database Including drawings and bill of materials•Developed device verification plans, protocols and verification summary reports based on internal engineering requirements and external regulatory requirements. Ref: IEC 60601, ISO 13485•Responsible to develop test and verification plans based on product requirements specifications•Sourced and qualified OEM components for Central Patient Monitoring System (ICS)•Drafted Mechanical and Electrical Safety Verification protocols(Verification Spec)•Engaged Design FMEA and MTBF activities•Designed and outsourced device under test fixtures•Experience with medical device disposables (ECG lead sets and catheters)•Legacy Central and Bedside Patient Monitoring device support•FDA 510k submission support•Participated in product steering team to evaluate intended use (Validation Plans) based on requirement specifications•Performed hardware gap analysis between legacy systems and developmental systems•Hardware engineering representative for the Central Patient Monitoring System cross functional team •Designed and retrofitted custom components for obsoleted OEM components/subsystems

Developed process verification plans, protocols and verification summary reports based on internal engineering requirements and external regulatory requirements. Ref: FDA 21 CFR part 820 (GMP)Evaluated manufacturing procedures and processes for completeness and inefficiencies Instituted lean manufacturing techniques and Poka-yoke in a cellular based manufacturing environment

Developed process verification plans, protocols and verification summary reports based on internal engineering requirements and external regulatory requirements. Ref: FDA 21 CFR part 820 (GMP)•Evaluated manufacturing procedures and processes for completeness and inefficiencies •Instituted lean manufacturing techniques and Poka-yoke in a cellular based manufacturing environment•IQ,OP and QP development

Managed and assisted in QA and test plan development and deployment•Managed and maintained the quality management system (QMS)•Conducted Internal Audits base on ISO900 requirements•Responsible to develop test and verification plans based on product requirements specifications•Designed and outsourced device under test fixture•Developed functional test fixtures with Labview and Testpoint application to acquire measurements and to control auxiliary GPIB test equipment.

Maintained critical RF communication systems

Maintained critical RF communication systemsHonorably discharge