Alan King Email & Phone Number

Amsterdam, Noord-Holland, Nl

Lead organizational strategies for manufacturing and service activities across Philips sleep and respiratory care therapy product portfolio globally, with oversight of Manufacturing Engineering, Test Engineering and Service Engineering teams. • Facilitating root cause investigations and executing correction action plans to address Quality Management System (QMS) deficiencies to meet 21 CFR 820 regulations pertaining to Document Control (Subpart D), Production & Process Controls (Subpart G), Acceptance Activities (Subpart H), Labeling & Packaging Control (Subpart K), and Records (Subpart M), to resolve ongoing Consent Decree inspections• Modernizing the QMS to eliminate non-value added, and obsolete, quality system documents (QSD) and simplify processes to ensure adequate adherence to 21 CFR 820 and ISO 13485 regulations• Leading transfer activities to relocate manufacturing of 4 product lines and aftermarket support repair kits to third party contractor• Supporting internal (Philips) and external (FDA TUV, SGS, MHRA) audits as primary lead for industrialization

Amsterdam, Noord-Holland, Nl

Manage manufacturing and service test strategies for the home respiratory product portfolio, comprised of home ventilators, airway clearance devices, and oxygen concentrators, with ownership of automated test equipment (ATE) and industrialization activities across 9 global sites. Significant accomplishments:• Executed the equipment build strategy for a $2.7 million investment in ATE with a two-month delivery to increase manufacturing of the Trilogy Evo Ventilator four-fold to meet demands for COVID-19 response• Integrated new non-invasive ventilators into existing high-volume CPAP manufacturing and test strategy within six-weeks enabling the delivery of 20,000 Emergency Use Authorization (EUA) devices within three-months from launch for COVID-19 response• Identified and led opportunities to increase the CoughAssist and A-Series Ventilator manufacturing first pass yield (FPY) from low 80% up to 90% target through iterative equipment and software continuous improvement initiatives• Partnered with external 3rd – party contract manufacturing sites to deploy and maintain duplicate manufacturing lines for Trilogy Evo Ventilator at Flex and Dreamstation 2 CPAP at Kimball• Conducted eleven corrective and preventative action (CAPA) investigations, performed root cause analysis (RCA) using cause mapping methodology, and deployed appropriate measures to correct and prevent deficiencies related to industrialization equipment and process• Owned and streamlined quality management system (QMS) processes and instructions for the design and acceptance of equipment and software• Supported multiple internal (Philips) and external (FDA TUV, SGS, MHRA) audits as primary lead for industrialization equipment and software

Amsterdam, Noord-Holland, Nl

Developed and tested ATE software and systems and served as team leader for new design and sustaining activities of manufacturing and service test equipment and software. Significant accomplishments:• Architected a test and diagnostic user interface, using LabVIEW event-based producer-consumer and state machine architectures, for the service of the Trilogy Evo Ventilator and reusable/scalable for future products• Established a digital weekly management graphical user interface (GUI), using LabVIEW event-based architecture, to track and trend key performance indicators (KPI) and metrics via remote team sessions• Facilitated teams to identify manufacturing and test requirements for three new product introductions and remediated historical requirement documents for three product transfers into local manufacturing sites• Implemented tracking system to document and track all discrepancies found during software verification and validation activities with over 350 discrepancies logged and resolved since deployment• Authored 200+ software verification & validation (V&V) protocols and reports to ensure the quality of custom test software against requirements and to prepare equipment for additional process validation (IQ/OQ/PQ) activities

West Mifflin, Pa, Us

Identified the initial requirements and program details for a new Control System Security Program

West Mifflin, Pa, Us

Managed technical drafting, graphics, and multimedia engineering design services with an emphasis on CAD drawings for instrumentation and control equipment. Significant accomplishments:• Project managed the remediation of 80+ multi-page instrumentation and control schematics into AutoCAD for document preservation and maintainability, tracking against project schedule and identifying alternative resources to meet deadlines • Developed and deployed tracking of monthly department planned vs actual financial spend across multiple cost centers

West Mifflin, Pa, Us

Developed and tested software and systems for the Instrumentation and Control testing program and served as team leader for new test programs. Significant accomplishments:• Co-designed a “Reconfigurable Software Verification Platform” – a National Instruments PXI-based embedded system configurable to perform testing of 20+ different embedded VME applications• Emulated reactor control rod responses, using LabVIEW FPGAs, to mimic equipment responses for manual system integrated instrumentation and control testing• Programmed a LabVIEW GUI for executing MS Excel test scripts for automated software testing• Created master control panel emulation in LabVIEW for simulating control commands for manual system integrated instrumentation and control testing• Produced automated test scripts, consisting of thousands of test cases, and manual test plans for complete functional and regression testing of instrumentation & control equipment and software