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.
• 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.
• 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.
• 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.
• 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.
• 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.

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).

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.
• 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