Phone 435-***-****

Grantsville Utah, *****

ac335k@r.postjobfree.com

Kendall Sandberg

Summary of qualifications

** ***** ******* * ******** Engineering team as manager

** ***** ******* ******* **ftware development teams as Project Lead

17 years leading and developing medical device software in highly regulated industry

7+ years working with and coordinating activities of cross functional, cross-cultural, and remote team members

2 years SQA-related work (writing & executing test plans/protocols, quality analysis, and writing software procedures)

Key, recent technologies, methodologies, OSs, and languages experience: Medical Device Software, Eclipse, uControllers, Linux, Windows, Thread-X, Nucleus, Parasoft, DDTS, Clearcase, Clearquest, DOORS, DICOM, C, C++, SQA, ISO 13485, 21 CFR 820

Professional experience

Oct 2016 – Aug 2017 Great Basin Scientific Salt Lake City, Ut

Software Engineering Manager

Led small team of software engineers, both direct reports and contract engineers, to complete development of 2nd generation molecular diagnostic analyzer software as well as begin the 3rd generation

Coordinated all software and many system efforts of development, verification, and validation

Authored requirements documents, test protocols, and reports as well as executed test protocols

Wrote file access and configuration file subsystem software (C code)

Re-wrote Software Development Procedures to improve efficiency and to be FDA-compliant

Technologies: Medical device software, Eclipse, C, MS Windows, Labview, STM32 family of uController.

2016 - 2016 GEHealthcare Salt Lake City, Ut

Software Infrastructure and Test Manager

Led team of 8 software engineers (direct reports) and 9 contract engineers

Led effort to improve software development and test environment

Led team of engineers to improve development and testing infrastructure

Investigate and implement leaner software development processes

Investigate and replace development, test, and collaboration tools with improved and more effective tools

Technologies: Linux, medical device software, DICOM, C, C++, Image Visualization, ClearCase, DOORS (Req. Management), Parasoft test tools, Squish test tools, Jenkins build automation tools, various home-grown results reporting tools, ISO 13485, 21 CFR 820.

2008 - 2016 GEHealthcare Salt Lake City, Ut

Workstation Software Platform Manager

Led team of 9-11 software engineers (direct reports), up to 9 contractors, and 20+ remote software engineers (dotted line reports)

Led a portion of the software team to develop, nearly from scratch, a new X-ray imaging system. My team’s focus was primarily the HW interfaces including motion control, collimator, X-ray generator, and X-ray controls.

Conducted performance reviews, budgets (some), team problem solving, hiring, training, oversight, assignments, etc.

Cross-cultural, extended teams (US, India, China)

Led the team through the business’s consent decree with FDA to completely overhaul our software development and testing processes to be fully FDA compliant

Was the face of the software team while being audited by 3rd party auditors

Technologies: Linux, embedded software, Thread-X and Nucleus RTOS, QT, medical device software, DICOM, C, C++, Image Visualization, ClearCase, DDTS, DOORS (Req. Management), Parasoft test tools.

2000 - 2008 GEHealthcare Salt Lake City, Ut

Software Project Lead

Led various sized software projects and teams (2 – 30 team members)

Software Process Improvement Lead (led in complete re-write of all SW processes and procedures)

Developed software for the Uroview Product X-ray system (device and video format control)

Cross-functional and cross-cultural extended teams (US, India, France)

Lead Project Integrator (cross functional lead for product refresh project)

Technologies: Real-time embedded software development, Thread-X and Nucleus RTOS, Shlaer-Mellor OOA/OOD, medical device software, Six sigma, Ethernet, DICOM, Serial Comm., C, C++, ClearCase, PVCS, DDTS, DOORS

1997 – 2000 Pioneer Digital Technologies Salt Lake City, Ut

Software Engineering Project Lead & Team Manager

Manage 8-12 software engineers (hiring, training, oversight, review, assignments, etc.)

Manage all aspects of set-top box controller software project

Work with cross functional and cross cultural extended teams (US, Japan)

Technologies: PC apps, real-time software control, MS Windows NT, DCOM, FSK encoded communication over cable, DES encryption, OOA/OOD, C, C++

Education

DeVry Institute of Technologies Phoenix, Az

Bachelor’s Degree in Electronics Engineering Technologies

Other courses & certifications: DFSS Six Sigma Greenbelt, ISO14971 Software Lifecycle and Risk Management, Design Controls Regulations for Medical Devices Manufacturers, Reliability Engineering.

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