Kevin Bach
Director of Engineering - Human Factors and Test Engineering at Tensentric- Claim this Profile
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Bio
Eric Cooper
Kevin and I have worked closely together for the last 2 years to implement a major enterprise level computer application. I have been the primary consultant on the job with Kevin being the primary IT contact at Gore. I have found that Kevin's level of IT experience to be exceptional. He has a strong understanding of IT concepts, databases and programming. Many of the customers with whom I work to implement our software end up delegating almost all the work to me to perform because they do not have the level of expertise necessary. Kevin, however, has caught onto the system very quickly and rarely now do I need to get involved except to be a sounding board for Kevin's ideas or in the event that something truly unique arises. I would highly recommend Kevin for any position within IT. He has proven to me that he is quite capable of learning with little direction, is self-motivated, and has the necessary experience and logical mind for troubleshooting any sort of application.
Haven McCall
Kevin has been heavily involved in a software application for my team. He took on this commitment and never looked back. He has aggressively worked through some of the challenges that we have encountered and made significant improvements to the system. He has been a great asset to our team and we would not have had the success we have seen without his IT role on our team.
Eric Cooper
Kevin and I have worked closely together for the last 2 years to implement a major enterprise level computer application. I have been the primary consultant on the job with Kevin being the primary IT contact at Gore. I have found that Kevin's level of IT experience to be exceptional. He has a strong understanding of IT concepts, databases and programming. Many of the customers with whom I work to implement our software end up delegating almost all the work to me to perform because they do not have the level of expertise necessary. Kevin, however, has caught onto the system very quickly and rarely now do I need to get involved except to be a sounding board for Kevin's ideas or in the event that something truly unique arises. I would highly recommend Kevin for any position within IT. He has proven to me that he is quite capable of learning with little direction, is self-motivated, and has the necessary experience and logical mind for troubleshooting any sort of application.
Haven McCall
Kevin has been heavily involved in a software application for my team. He took on this commitment and never looked back. He has aggressively worked through some of the challenges that we have encountered and made significant improvements to the system. He has been a great asset to our team and we would not have had the success we have seen without his IT role on our team.
Eric Cooper
Kevin and I have worked closely together for the last 2 years to implement a major enterprise level computer application. I have been the primary consultant on the job with Kevin being the primary IT contact at Gore. I have found that Kevin's level of IT experience to be exceptional. He has a strong understanding of IT concepts, databases and programming. Many of the customers with whom I work to implement our software end up delegating almost all the work to me to perform because they do not have the level of expertise necessary. Kevin, however, has caught onto the system very quickly and rarely now do I need to get involved except to be a sounding board for Kevin's ideas or in the event that something truly unique arises. I would highly recommend Kevin for any position within IT. He has proven to me that he is quite capable of learning with little direction, is self-motivated, and has the necessary experience and logical mind for troubleshooting any sort of application.
Haven McCall
Kevin has been heavily involved in a software application for my team. He took on this commitment and never looked back. He has aggressively worked through some of the challenges that we have encountered and made significant improvements to the system. He has been a great asset to our team and we would not have had the success we have seen without his IT role on our team.
Eric Cooper
Kevin and I have worked closely together for the last 2 years to implement a major enterprise level computer application. I have been the primary consultant on the job with Kevin being the primary IT contact at Gore. I have found that Kevin's level of IT experience to be exceptional. He has a strong understanding of IT concepts, databases and programming. Many of the customers with whom I work to implement our software end up delegating almost all the work to me to perform because they do not have the level of expertise necessary. Kevin, however, has caught onto the system very quickly and rarely now do I need to get involved except to be a sounding board for Kevin's ideas or in the event that something truly unique arises. I would highly recommend Kevin for any position within IT. He has proven to me that he is quite capable of learning with little direction, is self-motivated, and has the necessary experience and logical mind for troubleshooting any sort of application.
Haven McCall
Kevin has been heavily involved in a software application for my team. He took on this commitment and never looked back. He has aggressively worked through some of the challenges that we have encountered and made significant improvements to the system. He has been a great asset to our team and we would not have had the success we have seen without his IT role on our team.
Credentials
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Design for Six Sigma - Green Belt
MedtroincMay, 2015- Nov, 2024
Experience
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Tensentric
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United States
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Medical Equipment Manufacturing
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1 - 100 Employee
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Director of Engineering - Human Factors and Test Engineering
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Nov 2022 - Present
Tensentric is a leader in contract Design R&D and Manufacturing for developing medical devices, in vitro diagnostic systems, and gene and cell therapy solutions.. In my role, I will be leading the Human Factors/UX, Test Engineering and Bio/Chem disciplines while continuing to provide excellent partnerships and engineering work to clients looking to obtain their company's goals Tensentric is a leader in contract Design R&D and Manufacturing for developing medical devices, in vitro diagnostic systems, and gene and cell therapy solutions.. In my role, I will be leading the Human Factors/UX, Test Engineering and Bio/Chem disciplines while continuing to provide excellent partnerships and engineering work to clients looking to obtain their company's goals
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Boston Scientific
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United States
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Medical Equipment Manufacturing
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700 & Above Employee
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Sr. Software/Firmware R&D Engineer Manager
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Jan 2021 - Nov 2022
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Medtronic
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United States
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Medical Equipment Manufacturing
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700 & Above Employee
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Test Engineering Manager
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Aug 2017 - Jan 2021
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Medtronic Brain and Spine Therapies
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Medical Equipment Manufacturing
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300 - 400 Employee
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Senior Supervisor, Test Engineering
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Apr 2016 - Aug 2017
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Test Engineering Supervisor
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May 2015 - Apr 2016
More to come.....
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Sr. Software Design Assurance Quality Engineer
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Nov 2011 - May 2015
Following FDA Quality System Regulations, Medical Device Directive, ISO 13485, ISO 14971, and ISO 62304 standards I • Participate in product development cycle by reviewing software project documentation, participating in product risk assessments, and working closely with Product Development to develop appropriate verification and validation testing requirements. • Work cross-functionally to implement improvements to the software life cycle, including the establishment of risk management… Show more Following FDA Quality System Regulations, Medical Device Directive, ISO 13485, ISO 14971, and ISO 62304 standards I • Participate in product development cycle by reviewing software project documentation, participating in product risk assessments, and working closely with Product Development to develop appropriate verification and validation testing requirements. • Work cross-functionally to implement improvements to the software life cycle, including the establishment of risk management as an integral part of the quality management system as an overall framework for the application of appropriate software engineering methods and techniques. • Create and revise Standard Operating Procedures (SOPs) to support the Quality System in regards to software and system design. • Identify and implement software process metrics for the software product development life cycle. Develop, analyze and monitor metrics pertaining to software defects uncovered during development, testing and post-release. • Recommend and lead corrective and preventive actions to improve software product quality. Ensure documentation and findings are completed on time and in a timely manner in accordance with regulatory agency standards and procedures. • Provide solutions to a wide range of difficult challenges. Determine and develop solutions that are imaginative, thorough, practicable, and consistent with organizational objectives. • Provide QA oversight to assigned suppliers. Disposition nonconforming product at the Material Review Board meetings. Interface as necessary with suppliers to ensure product specifications are met. Lead supplier audits and assessments. • Promote continuous improvement through the use of such tools as Lean, Six Sigma and Kaizen. • Follow all Quality System Practices as defined by Medtronic Navigation’s practices, policies and Standard Operating Procedures (SOPs) to ensure that FDA, ISO and European Medical Device quality standards and regulations are met.
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U.S. Soccer Federation
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United States
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Spectator Sports
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700 & Above Employee
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Official - Grade 6
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May 2003 - Jul 2014
Official - grade 6 Official - grade 6
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Boston Scientific
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United States
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Medical Equipment Manufacturing
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700 & Above Employee
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Sr. Programmer/Analyst:Technical Leadership
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Jun 2008 - Nov 2011
Technical Lead for $6.5MM global software project (EMC Documentum). Supervised and responsible for 5 off-site developers, 1 on-site developer and 2 support employees. PM for 3 technical work streams, multiple integrations (SAP), trainings. Conflict resolution, project metric reporting, PM for technical aspects planning through stabilization Technical and Team Lead for AssurX's CATSWeb software with 3 total team members Incorporated Steering Committee with senior management to align… Show more Technical Lead for $6.5MM global software project (EMC Documentum). Supervised and responsible for 5 off-site developers, 1 on-site developer and 2 support employees. PM for 3 technical work streams, multiple integrations (SAP), trainings. Conflict resolution, project metric reporting, PM for technical aspects planning through stabilization Technical and Team Lead for AssurX's CATSWeb software with 3 total team members Incorporated Steering Committee with senior management to align business and IS expectations, conflict resolution, provide support metrics Led several software upgrades following IS software and quality system validation protocol Owned and updated support, disaster recovery and FDA inspired software validation documentation Preformed software customer support at a high level SQA for small/medium projects Provided Sr level Business Analyst/Software Architect skills to get customers software solution to meet their needs Project manager for several small/medium projects outside main commitments Show less Technical Lead for $6.5MM global software project (EMC Documentum). Supervised and responsible for 5 off-site developers, 1 on-site developer and 2 support employees. PM for 3 technical work streams, multiple integrations (SAP), trainings. Conflict resolution, project metric reporting, PM for technical aspects planning through stabilization Technical and Team Lead for AssurX's CATSWeb software with 3 total team members Incorporated Steering Committee with senior management to align… Show more Technical Lead for $6.5MM global software project (EMC Documentum). Supervised and responsible for 5 off-site developers, 1 on-site developer and 2 support employees. PM for 3 technical work streams, multiple integrations (SAP), trainings. Conflict resolution, project metric reporting, PM for technical aspects planning through stabilization Technical and Team Lead for AssurX's CATSWeb software with 3 total team members Incorporated Steering Committee with senior management to align business and IS expectations, conflict resolution, provide support metrics Led several software upgrades following IS software and quality system validation protocol Owned and updated support, disaster recovery and FDA inspired software validation documentation Preformed software customer support at a high level SQA for small/medium projects Provided Sr level Business Analyst/Software Architect skills to get customers software solution to meet their needs Project manager for several small/medium projects outside main commitments Show less
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Official
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2008 - Nov 2011
Collegiate Soccer Official Elected to participate in post-season officiating Collegiate Soccer Official Elected to participate in post-season officiating
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Applications Programmer
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May 2004 - Jun 2008
- Use PMI project mgmt procedures for all projects - Performed Business Analyst duties such as gathering business and functional requirements, writing Quality Sytstem documentation, test cases, IQ, OQ, PQ, etc - Leading a group of tech/business associates in implementation of divisional complaint handling software (AssurX). Assist in creation, writing, implementing of IT and business procedures, validation and quality system documentation. - Maintainence and support of Product… Show more - Use PMI project mgmt procedures for all projects - Performed Business Analyst duties such as gathering business and functional requirements, writing Quality Sytstem documentation, test cases, IQ, OQ, PQ, etc - Leading a group of tech/business associates in implementation of divisional complaint handling software (AssurX). Assist in creation, writing, implementing of IT and business procedures, validation and quality system documentation. - Maintainence and support of Product Surveillance Group (Complaints) software and data. Intimate customer contact and support. - writing of SQA NOCs, test cases, requirements - Excellent knowledge of quality system mandated by the FDA. - Appointed to IT’s interview team for 6 of last 7 positions. - Creation/support of VB.NET, VB6, Access97,PowerBuilder, ColdFustion applications for Sales, Mfg, Complaints, and Legal depts. using SQL Server 2000 or Oracle - Good knowledge of FDA regs for SQA and Complaint Handling. (21 CFR Part 11, etc) Show less - Use PMI project mgmt procedures for all projects - Performed Business Analyst duties such as gathering business and functional requirements, writing Quality Sytstem documentation, test cases, IQ, OQ, PQ, etc - Leading a group of tech/business associates in implementation of divisional complaint handling software (AssurX). Assist in creation, writing, implementing of IT and business procedures, validation and quality system documentation. - Maintainence and support of Product… Show more - Use PMI project mgmt procedures for all projects - Performed Business Analyst duties such as gathering business and functional requirements, writing Quality Sytstem documentation, test cases, IQ, OQ, PQ, etc - Leading a group of tech/business associates in implementation of divisional complaint handling software (AssurX). Assist in creation, writing, implementing of IT and business procedures, validation and quality system documentation. - Maintainence and support of Product Surveillance Group (Complaints) software and data. Intimate customer contact and support. - writing of SQA NOCs, test cases, requirements - Excellent knowledge of quality system mandated by the FDA. - Appointed to IT’s interview team for 6 of last 7 positions. - Creation/support of VB.NET, VB6, Access97,PowerBuilder, ColdFustion applications for Sales, Mfg, Complaints, and Legal depts. using SQL Server 2000 or Oracle - Good knowledge of FDA regs for SQA and Complaint Handling. (21 CFR Part 11, etc) Show less
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Official
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2004 - 2008
Collegiate soccer official for the state of Arizona Collegiate soccer official for the state of Arizona
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Northern Arizona University
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United States
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Higher Education
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700 & Above Employee
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Systems Analyst I
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Sep 2003 - Oct 2004
- Develop .NET platform and web applications for students worldwide with ASP.NET and JavaScript. Oracle 9i and Access XP, taught IT team - SQL Server 200 and Access XP database development, installation, and maintenance - Assist Support Systems Analyst Sr. with 130 node XP environment, employee and student technology issues, rebuild/maintain user machines - Employee support and troubleshooting - Introduced to Macromedia Flash - Build, design, and implement IIS web server… Show more - Develop .NET platform and web applications for students worldwide with ASP.NET and JavaScript. Oracle 9i and Access XP, taught IT team - SQL Server 200 and Access XP database development, installation, and maintenance - Assist Support Systems Analyst Sr. with 130 node XP environment, employee and student technology issues, rebuild/maintain user machines - Employee support and troubleshooting - Introduced to Macromedia Flash - Build, design, and implement IIS web server, maintaince, taught IT team - Windows 2003 server installation and maintenance (minimal) Show less - Develop .NET platform and web applications for students worldwide with ASP.NET and JavaScript. Oracle 9i and Access XP, taught IT team - SQL Server 200 and Access XP database development, installation, and maintenance - Assist Support Systems Analyst Sr. with 130 node XP environment, employee and student technology issues, rebuild/maintain user machines - Employee support and troubleshooting - Introduced to Macromedia Flash - Build, design, and implement IIS web server… Show more - Develop .NET platform and web applications for students worldwide with ASP.NET and JavaScript. Oracle 9i and Access XP, taught IT team - SQL Server 200 and Access XP database development, installation, and maintenance - Assist Support Systems Analyst Sr. with 130 node XP environment, employee and student technology issues, rebuild/maintain user machines - Employee support and troubleshooting - Introduced to Macromedia Flash - Build, design, and implement IIS web server, maintaince, taught IT team - Windows 2003 server installation and maintenance (minimal) Show less
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Applications Programmer
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May 2000 - Aug 2003
- Designed, presented, developed, and deployed windows and web applications across company of 100 with development team (VB6, VB.NET, ASP.NET, SQL Server 2000) - Organize development workshop – code review, expose standards, and idea and question sharing - Administration and development of applications, components, and services using .NET suite, VB6, and SQL 2000 languages - write SQL Server 2000 database scripts (functions, procedures, etc) - Designed and developed data processing… Show more - Designed, presented, developed, and deployed windows and web applications across company of 100 with development team (VB6, VB.NET, ASP.NET, SQL Server 2000) - Organize development workshop – code review, expose standards, and idea and question sharing - Administration and development of applications, components, and services using .NET suite, VB6, and SQL 2000 languages - write SQL Server 2000 database scripts (functions, procedures, etc) - Designed and developed data processing system for United Kingdom - Production support including troubleshooting application issues, server maintenance, application, processes, and efficency of components Show less - Designed, presented, developed, and deployed windows and web applications across company of 100 with development team (VB6, VB.NET, ASP.NET, SQL Server 2000) - Organize development workshop – code review, expose standards, and idea and question sharing - Administration and development of applications, components, and services using .NET suite, VB6, and SQL 2000 languages - write SQL Server 2000 database scripts (functions, procedures, etc) - Designed and developed data processing… Show more - Designed, presented, developed, and deployed windows and web applications across company of 100 with development team (VB6, VB.NET, ASP.NET, SQL Server 2000) - Organize development workshop – code review, expose standards, and idea and question sharing - Administration and development of applications, components, and services using .NET suite, VB6, and SQL 2000 languages - write SQL Server 2000 database scripts (functions, procedures, etc) - Designed and developed data processing system for United Kingdom - Production support including troubleshooting application issues, server maintenance, application, processes, and efficency of components Show less
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Education
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2005 - 2007
Northern Arizona University
B.S.B.A, Computer Information Systems -
2003 - 2007
Northern Arizona University-The W. A. Franke College of Business
Computer Information Systems. B.S.B.A, Computer Information Systems -
1994 - 1998
University of Kentucky
Environmental Biology
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