Greg K.

Experience

• Werfen, AID, San Diego, CA Senior Manager, Systems Integration · Full-time Nov 2024 – Apr 2026 1 yrs 5 mos San Diego, CA, United States Led systems integration team wo across hardware, software, and reagents, overseeing requirements, risk management, V&V, transfer to manufacturing, and obsolescence while ensuring compliance with SOPs and QSR/IVDR/ISO. Delivered the Aptiva and KMC on‑market portfolio under budget, driving multiple platform software releases through V&V/ECO within target timelines. Improved system reliability using DMAIC by identifying and resolving root causes of performance issues. Managed external contract manufacturers to deliver projects on schedule and under budget, while securing third‑party supplier continuity through resolution of technical specifications and implementation of complex corrective actions. Strengthened organizational capability by defining team roles, performing a skills‑gap analysis, and hiring for key positions. Standardized the SOW framework to align software, systems, service, and marketing teams on features, defects, platform expectations, and security.
• Product Development Engineering QuidelOrtho Corporation · Full-time Apr 2009 – Sep 2023 14 yrs 5 mos San Diego, CA, United States Associate Director, Product Development Engineering Feb 2020- Sep 2023
  Senior Manager, Product Development Engineering Apr 2017- Feb 2020
  Manager, Product Development Engineering Apr 2013-Apr2017
  Staff, Product Development Engineering Apr 2011-Apr 2013
  Product Development Engineering Apr 2009-Apr 2011
  
  Spearheaded innovation initiatives to advance diagnostic system technology and projects. Lead internal teams in the brainstorming and development of prototypes to establish intellectual property for diagnostic systems. Obtained feedback/input from customers, marketing, and other key stakeholders. Used this information to develop requirements and prototypes for early-stage concepts and facilitated end-user feedback. Iterated designs as necessary then facilitated human factors testing on prototype designs to assess use-related risks. Led team in finding and prioritizing key system/product requirements and test methods. Established concept system architecture, and proactively mitigated technical risks. Collaborated with mechanical, electrical, system, software engineers and assay development scientists to progress technology for medical diagnostic systems. Represented R&D engineering related to technology discovery, innovation, and concept development. Participated in selection of third-party vendors for design and manufacture of instruments and disposables. Managed technical relationships with third-party contract manufacturers locally and globally. Drove continuous improvement efforts within R&D and manufacturing. Managed department activities related to Corrective Action Preventative Action (CAPA), Material Review Board (MRB), Non-Conformance Reports (NCRs), yield improvement, process efficiency, and material cost reduction. Responsible for product and process Failure Modes and Effects Analysis (FMEA). Collaborated with marketing and directly with customers to help ensure the development and testing of prototypes met the market and customer requirements. Created designs for molecular diagnostic disposables and improvements for immunochemical instruments, disposable designs, and manufacturing processes. Created prototype designs and developed them for clinical trial and production. Developed manufacturing lines for clinical trials and scaled up lines to meet production forecasts and timelines. Created dimensional stack-up analysis that accounted for manufacturing and instrument system variation to create assay specific software files which ended false negative results on Sofia system. Improved Sofia system capability by improving calibration process and standards.
• Senior Mechanical Engineer Luminous Medical · Full-time Nov 2006 – Sep 2009 2 yrs 10 mos Carlsbad, CA, United States Responsible for peristaltic pump modules and IV tubing disposable set designs. Generated design input documentation defining the specifications needed for Pump module and disposable. Generated the tubing cartridge that included mixing ISO luers and pressure transducers. Developed prototypes through rapid machining, 3D printing, prototype injection molds and selection of off the shelf components. Selected Servo motors and controllers for prototype pump equipment. Participated in live animal tests to evaluate the system. Generated disposable assembly process, assembly fixtures designs and leak test fixture with custom manifold and test programs. Preformed documentation of process and executed IQ/OQ/PQ validation.
• Senior Mechanical Engineer Underwater Kinetics · Full-time Jun 2006 – Nov 2006 5 mos Poway, CA, United States Designed and prototyped underwater dive light. Designed with catalysts to absorb hydrogen gas from batteries. Selected on/off button switches, designed sheet metal and spring design for contacts. Traveled to China to source parts. Selected load out case wheel bearing and design urethan over molds parts for wheels, flashlight bezels, and switch buttons.
• Senior Mechanical Engineer SenDx Medical · Full-time Sep 2003 – Jun 2006 2 yrs 9 mos Carlsbad, CA, United States Design engineer of blood gas and electrolyte analyzer and disposables system. Collaborated with industrial designer on overall design concept then used top-down design methods to design detailed parts. Design included plastic, sheet metal, machine, die cut parts, electronic enclosure, as well as filled pouches and luer sealing devices. Designed with SolidWorks and PDM Works. Performed material selection, stress analysis, and DFMA/PFMEA. Setup manufacturing lines per ISO 13485 for clinical trials. Prototype parts created using rapid SLA/SLS prototyping methods. Worked with US, Chinese, and European vendors to create production parts. Created validation protocols, performed testing, and drafted reports for the production release of product.
• Senior Mechanical Engineer/Sustaining – Instrument/Disposable Alaris Medical Systems · Full-time Oct 1997 – Sep 2003 5 yrs 11 mos Carlsbad, CA, United States Worked in San Diego, United Kingdom, and Mexico locations. Designed EMI/EMC enclosures and performed EMC/EMI verification testing. Designed strain beam pressure transducers. Worked with manufacturer to design ultra sonic emitter/collector sensors for the detection of air bubbles. Generated 3D CAD models and part drawings utilizing SDRC Ideas and SolidWorks. Detailed drawings
  using geometric tolerances. Created sheet metal, extruded, and machined parts. Created packaging design and ship testing. Generated FMEAs, bills of materials, manufacturing instructions, and engineering change orders. Designed experiments to perform reliability and qualification testing. Performed installation, operation, process, and equipment qualifications. Performed sterilization qualifications and cost analysis. Followed FDA and ISO regulations for class II devices.