Jerry Kowalski Email & Phone Number

Santa Fe Springs, Ca, Us

Santa Fe Springs, Ca, Us

• Software Development Lead/Manager for class II medical device for IVD, the BioCode MDx 3000. FDA cleared.• Developed SOP for software development of medical devices, based on IEC 62304.• Staffed team with internal software developers and software contractors.• Interface with hardware and software vendors. • Developed LIMS interface to middleware, HL7 over TCP/IP.• Responsible for all medical device software, software process owner.• Software Developer; C# .NET Visual Studio 2017, WPF, hardware interface control.

Rancho Santa Margarita, Ca, Us

Successfully released class II medical device for use in surgery; UL, CE and FDA clearance.Created new software development department:• Developed SOP for software development of medical devices, based on IEC 62304.• Developed software development plan for class II medical device (surgical).• Created software development team and software test team.• Software Lead of embedded ARM software for class II medical device. • Managed software architect, software developers, requirements analyst, and consultants.• Recruited, trained, mentored, and coached software developers.• Responsible for all medical device software, software process owner.• Empowered team to meet project objectives using PSP/TSP and Agile methodologies.• Reviewed, edited, and approved software architecture, requirements, detailed designs, and coding standards.• Directed implementation of automated software build system, white-box regression testing, multiple static analysis tools for different areas of coverage, and automated source code documentation tool.• Brought in training classes for PSP/TSP, requirements writing and detailed design documentation.• Created change control board to control design change across multiple disciplines.

Brea, California, Us

• Supervised software, firmware, database, architect and test engineers.• Developed Microsoft Windows applications using MS Visual Studio, C++, C#, VB, WPF/XAML.• Software involved extensive hardware, firmware and chemistry user interface software.• Software representative for Core Project Teams (encompassing all stakeholders).• Involved with all phase of Software Development Life Cycle.• Managed software engineers at multiple sites; Orange County, San Diego and Palo Alto. • Served as Representative to the Corporate Quality System as the Software Process Owner.• Responsible for budgeting, hiring and training engineers.• Projects: DNA Analysis System, Protein Analysis System,Centrifuge System.

Brea, California, Us

Software development for gas monitoring systems. C++ for MS Windows and OS2.

Software development for air quality monitoring systems. C, C++.

Deerfield, Illinois, Us

Software development for blood analysis system. C and Unix.

Developed custom software and electronics interface between Automated Test Equipment (ATE) and client circuit boards under test.

Supervised electronics technicians for commercial grade interactive video graphics (vector and raster). Wrote custom diagnostic programs to test hardware’s graphic capabilities. Hands-on electronics troubleshooting and mentoring.

Developed custom electronics interfaces between Automated Test Equipment (ATE) and client circuit boards under test.

Supervised a team of applications engineers developing custom software and electronics interfaces between ATE and client circuit boards under test.

Developed custom software and electronics interface between Automated Test Equipment (ATE) and client circuit boards under test.

System integration of large complex Automated Test Equipment (ATE).

Supervised team of electronics technicians.

Electronics Technician troubleshooting circuit boards to component level.

Field Service Engineer for electronic typing systems.