Lindsay Kough

TRIDENT 11

We solve problems, and construct and renovate buildings on behalf of veterans who have served our great nation.

UEI:  TT1ZZAJR9LX5
CAGE Code:  95F88
DUNS Number:  015451889

www.trident11.com

Chief Executive Officer

Clement J. Zablocki VA Medical Center

TRIDENT 11 manages Superintendent services for the "Upgrade Plumbing for Legionella Prevention" project at Clement J. Zablocki VA Medical Center; oversees subcontractor operations and ensures project compliance on behalf of the prime contractor, Richard Group, and the U.S. Department of Veterans Affairs; and implements and manages safety protocols and quality control measures ensuring project success.

Superintendent

Institute for Veterans and Military Families - IVMF

CEOcircle is a monthly peer accountability group for growth-stage companies looking to scale. Over the course of nine virtual huddles and four in person fly-in forum events, CEOs and executives can ask critical questions impacting their businesses today. Together, we learn from our peers and national experts alike how to take our company to the next level. Progress through the program is focused and measured based off self-set goals and helped by intentional and facilitated connections. Additionally, CEOcircle members also gain access to dedicated JPMorgan Chase Commercial Banking liaisons.

CEOcircle

Regional Lead Ambassador

The Ambassador Program is a dynamic 12-month program of entrepreneurial servant-leaders connecting military community business owners in the local entrepreneurial ecosystem. This volunteer role expands one's professional network while supporting budding veteran-owned businesses in one's community.

Ambassador

Veterans in Residence is a business incubator that provides Veteran and military spouse entrepreneurs and business owners with co-working space, local community, a national business network, and targeted support to grow their business.

Veterans in Residence is a partnership of WeWork and Bunker Labs.

https://bunkerlabs.org/veterans-in-residence/

Veterans in Residence Cohort 22-A

Veterans in Residence Cohort 21-B

Next Dynamics, Inc.

Next Dynamics Inc. is an emerging global leader in designing, manufacturing and integration of some of the world’s best-performing military technologies.  Next Dynamics currently holds numerous patents in the field of armaments, ballistics, weapons.

Our team is composed of some of the brightest minds in the field of armaments, ballistics, weapons as well as wide ranging global marketing strategists.

Advisory Board Member

Richard Group

Unpaid internship learning from top-tier construction professionals in various disciplines in Oklahoma, Arizona, and Illinois at Richard Group, a leading general contracting firm in the United States.

As a life-long learner, refined my hands-on skills in project management, estimating, marketing, business development, site supervision, and quality control acumen.

Intern (unpaid)

Bancroft Architects + Engineers

Bancroft Architects + Engineers is a service-disabled veteran-owned engineering firm, dedicated to pioneering the efficient design of highly technical electrical and mechanical systems.  The company was named in honor of the late Secretary of the Navy, George Bancroft, who established the United States Naval Academy in 1845.  The trademark signature that forms Bancroft’s company logo is actually the signature of George Bancroft, used with permission.

By 2009, Geo. Bancroft Engineering had earned its CVE certification as a Service Disabled Veteran Owned Small Business (SDVOSB) and had grown to 11 full-time engineers, each with sterling academic credentials that include multiple and advanced degrees from the world’s top schools.  With mechanical, electrical, civil, and aerospace engineers, Geo. Bancroft Engineering offered clients a range of engineering services, backed by a portfolio of project experience unlike any other set-aside firm in America.

Recognizing the need to broaden its scope of design expertise, Jenkins purchased one of the region’s most respected small architectural firms, Facilities Solutions Group, in 2011.  Known for their precision in designing intensely complex facilities for scientific, military, and life sciences clients around the world, Facilities Solutions Group had the added advantage of an impeccable project history that extends back into the late 1990s.  The name of the merged firm, Bancroft Architects + Engineers, reflects both the legacy of the original company with the historical connection to the Navy and Naval Academy as well as the full range of services on offer.

Now with 59 full-time architects and engineers working from regional offices around the United States, in addition to the Illinois headquarters, Bancroft continues to grow.

President

Senior Vice President

TRIDENT 11 is a subcontractor to a prime government contractor, Bancroft Architects + Engineers (BAE), in the disciplines of project management and other special duties supporting government contracting projects throughout the United States.  

BAE is an expert team of professionals specializing in the planning and design of highly technical and efficient facilities.  Please review BAE's body of work, and let me know how we may serve you.  

www.bancroft-ae.com

Director, Special Projects

Currently manage several US Department of Veterans Administration (VA) architecture and engineering projects in VA Medical Centers in California, Arizona, and Florida; and a contract pharmaceutical manufacturing facility in Connecticut.

Project Manager

Veterans In Residence

A partnership of WeWork and Bunker Labs, Veterans in Residence is a highly selective six-month startup incubator and leadership program that provides veteran and military family member entrepreneurs the community, business support, and workspace to help launch and grow their businesses.

WeWork Veterans in Residence
https://www.wework.com/veterans-in-residence

Cohort 22-A

Cohort 21-B

VETtoCEO

We are a community of veterans who connect through entrepreneurship and military training. We offer an online, 7-course entrepreneurship program featuring industry guest speakers and interactive modules. Our exclusive program is designed by veteran/entrepreneurs to educate transitioning warriors on the path to entrepreneurship as a business model. 

We offer the program to qualified/verified members of the military and veterans. We fund our programs through the generosity of leading corporations, grants, and individuals who have a passion for helping veterans.

www.vettoceo.org

Cohort 2019-01

CRC Surface Technologies

Founded in 1954, CRC Surface Technologies is a Nadcap-certified, AS9100-registered, and ITAR-registered, USG contractor who is a single-source chemical processing provider for the aerospace, defense, medical, semiconductor/electronics, space and heavy equipment industries.  Located in central Phoenix, AZ our multi-shift 65,000 square foot special processing facility services regional and national machine shops including OEMs such as Boeing, BAE Systems, Bombardier Aerospace, Eaton, General Electric, Honeywell, Hamilton Sundstrand, Goodrich, Northrop Grumman, Parker Aerospace, Bell Helicopter, Rolls Royce, Spirit AeroSystems, Space X, Woodward and many more.

Our 68-year-old corporation is one of the largest special processing companies in AZ offering over a 130 plating configurations and metal finishing services which include Anodize, Cadmium, Chem-Film, Chrome, Copper, Dow 7, Electroless Nickel, Grinding (ID/OD), Nickel, Nital Etch, Non-Destructive Testing, Passivate, Phosphate, Shot Peening and Silver.  Along with our array of surface treatment capabilities we provide value-added logistics solutions such as pick-up and delivery, testing, part identification, silk screening, assembly and more.

www.ChemResearchCo.com

Executive Vice President and Chief Business Development Officer

UNITED STATES DEPARTMENT OF THE NAVY

Political Appointee as Chief of Staff to the Under Secretary of the Navy, serving the second-highest ranking civilian official leading the United States Department of the Navy, with over 900,000 personnel (Sailors, Marines, reservists, and civilian personnel), and an annual budget of over $211 billion.  Served the Honorable Gregory J. Slavonic, RDML, USN, (Ret.), https://www.linkedin.com/in/greg-slavonic-b089586/, in the Senior Executive Service as a SES-III (three-star equivalent).

3rd Chief of Staff to the Under Secretary of the Navy

I help grow companies | Navy SEAL Veteran | Former Chief of Staff to the Under Secretary of the Navy (SES-III)

My why:   to serve God, country, and family by inspiring and empowering others to achieve their greatest potential living out their own why.

Gallop Strengths:   Self-Assurance | Achiever | Belief | Responsibility | Activator

Kolbe A Index:  5-5-7-3

We solve problems, and grow client companies in the United States and abroad.  We focus on innovation in architecture, engineering, healthcare, space, and defense.

CAGE Code:  95F88
DUNS Number:  015451889

www.trident11.com

Fullpower-AI

Fullpower®-AI delivers a complete IoT PaaS platform vetted and deployed worldwide, for machine learning, remote contactless biosensing, and end-to-end smart connected devices in life sciences, health, and biotechnology. In addition, Fullpower's platform is backed by 135+ patents and is ISO/IEC 27001 and SOC 2 Type II certified.

Responsible for managing the Regulatory and Compliance efforts for Fullpower®-AI and advancing its solutions into the healthcare and medical device spaces. 

- Management Representative for the company.
- Data Protection Officer for the company.
- Implemented an electronic Quality Management System.
- Reviewed and updated all QMS documents to be more fully compliant with QSR and ISO 13485.
- Reviewed and assisted in updating all product DHF documentation to be ready for US FDA 510(k) filing for Class II medical device.
- Worked with 3rd party vendors to ensure that their product documentation was complete and compliant with requirements.
- Drove compliance/security/privacy efforts to achieve ISO/IEC 27001 certification,  SOC 2 Type II attestation, and GDPR compliance.

Vice President of Regulatory Affairs

Device Design Solutions

Device Design Solutions was created to help companies get their medical device systems completed on time and on budget so they can be approved by the appropriate regulatory agencies and released to the market.

Getting your products to market and in the hands of your customers and patients is vital to allowing us to realize our mission of helping to improve human health.

Specializing in Medical Device R&D: Software and Hardware Engineering, Quality Assurance, Product - Project Development/Management, Manufacturing, and overall Leadership/Management.

•	Consult with medical device companies to assist with all product development activities.
•	Work with all employees, including Executive Management – C-Suite.
•	Review and recommend changes to:
           o	   Product and project management processes and activities.
           o	   Software and hardware engineering processes and activities.          
           o	   Manufacturing processes and activities.
           o	   Quality assurance processes and activities.
           o	   Regulatory compliance processes and activities.
           o	   Vendor qualification, review, and engagement.
           o	   Communication and decision-making processes.
           o	   Meeting management, meeting structure processes and activities.
           o	   Company culture and employee engagement.
           o	   Due Diligence.
           o	   Mergers and Acquisitions.
           o	   Intellectual Property posture and strategy.

TruMed Systems, Inc.

Responsible for maximizing TruMed Systems, Inc. engineering and manufacturing performance, hardware and software development and information security to help in achieving our business goals.  Provide leadership and strategic direction to the company’s overall engineering program, including all products and systems, business applications and tools for internal and external use and for expanding and leveraging product and systems to develop new and next generation opportunities.

*	Chief Security Officer for the company.
*	Responsible for all internal and external Engineering activities – System, Electrical, Mechanical, Software and Quality Assurance.
*	Responsible for all Manufacturing activities for multiple product lines, including new product manufacturing, sustaining engineering, rework/RMA, logistics.
*	Responsible for all vendor/partner management activities.
*	Responsible for intellectual property portfolio management.
*	Work with all cross-functional teams to mature processes and procedures to support company strategic growth initiatives.
*	Responsible for looking for, qualifying, and engaging with a second contract manufacturer outside the United States.

Executive Vice President Engineering

Biocare Medical

Managed multiple groups within the Quality and Regulatory department of up to 18 employees, contractors and interns including Quality Assurance, Quality Control, Quality Systems, Regulatory Affairs, and System Verification.
* Management Representative for the company.
* Responsible for taking the company through multiple second and third party audits.
* Lead the company through an overhaul/remediation of the Quality Management System to bring it in compliance with ISO 13485:2016. Resulted in a successful audit and ISO 13485:2016 certification.
* Lead the company through a subsequent update to the Quality Management System to bring it in compliance with Medical Device Single Audit Program (MDSAP) requirements. Resulted in a successful audit and MDSAP certification.
     * Overhauled the QMS Management Review and Internal Audit processes.
     * Started a new Post Market Surveillance program.
     * Instilled a new culture of Risk Analysis, including identification, analysis, and mitigation.
 * Work cross-functionally to decentralize quality ownership and accountability to all departments and to instill a quality-oriented mindset (Culture of Quality) in all day-to-day activities across the company.
* Work with senior management and C-suite to turn the company culture, including inter- and intra- team collaboration, meeting effectiveness, and decision-making.
* Certified ISO 13485:2016 Internal Auditor.
* Certified in Root Cause Analysis for Life Science Investigations.
* Attended Medical Device Single Audit Program (MDSAP) course.

Vice President, Quality and Regulatory Affairs

BioTelemetry, Inc.

Managed multiple groups within the R&D department of up to 45 full-time software, hardware, biomedical engineers, project managers, QA, contractors and interns domestically and internationally – 6 direct reports.
• Received highest engagement score in the company wide engagement survey.
• Defined and implemented corporate technical roadmap.
• Completed budgetary responsibility for multi-million-dollar R&D budget.
• Conducted due diligence for merger/acquisition partnerships and competitive analysis.
• Worked with government regulatory agency (FDA) and standards bodies.
• Drove all R&D aspects of Intellectual Property (IP) to ensure Freedom to Operate, working with lawyers, designers/architects/scientists, as required, to write/submit patentable inventions.
• Worked with global external vendors/partners to develop statements of work/contracts/development agreements.

Vice President, Research and Development

Managed the department of up to 15 full-time engineers, contractors and interns.
• Technology and architecture driver; the right tools and processes for best of class products.
• Drove product definition, architecture, development and ran project management for multiple concurrent projects.
• Worked significantly on building/repairing relationships between groups in San Diego and other local/remote groups.
• Managed tool selection process – requirements definition, vendor identification, pricing, purchasing.
• Drove late projects by performing requirement/implementation gap analysis and creating momentum and fostering ownership and accountability.
• Orchestrated all embedded and supporting PC application product software that includes mobile, cellular, Bluetooth, low power wireless (1GHz) technologies in C, C++, C#, and Java.

Director, Software Engineering

Hospira

Managed department of up to 80 full-time managers and engineers, contractors and interns including local, remote domestic and off-shore staff divided into five development teams.
• Oversaw all software development for entire company.
• Complete budgetary responsibility for multi-million dollar software development budget.
• Drove all project management and requirements definition activities including new development and support activities.
• Directed the definition and development of “game changing” products to customers.
• Introduced first Scrum/Agile development projects training developers on processes and running spin kick-off/close-out meetings and was the process champion gaining cross functional support.
• Worked with the customers on HIPAA, Healthcare IT, HL7 related issues.
• Drove system and software development and integration to streamline overall system performance and improve department’s reputation within company.
• Collaborated with government regulatory agency (FDA) and standards bodies.
• Worked on Intellectual Property (IP) team to ensure Freedom to Operate, working with designers/architects as required, for Hospira and to review patentable inventions.

Software Development Manager

Managed and led Engineers for Drug Library Editor and Medication Management Unit development teams acting as a manager, team leader, team builder, and advocate throughout all levels of management.
• Led all project management and requirements for projects delivered the most on time within the entire software department directly contributing to on time product delivery to customers.
• Drove system and software development and integration to streamline overall system performance.
• Managed other senior and junior software engineers, including interviewing, hiring, reviewing, mentoring, career guidance, tasking, design and code reviews.
• Led the design and development of “best of breed” features that greatly outpaced the competition.
• Developed and maintained project plans for multiple versions of products including task definition, prioritization, assignment, updating and status reporting.
• Provided technical support for fielded applications as required (first and second level).
• Provided 24/7 support for applications supporting hospital operations, managed escalation and resolution.
• Worked to foster an environment of open communication and positive attitude.

Senior Member Technical Staff

Maxim Systems, Inc.,

• Consistently delivered on time, quality versions of software deliverables maximizing utilization of resources directly resulting in company getting additional project funding from the customer.
• Drove significant systems integration activities across Department of Defense projects.
• Managed other senior and junior software engineers, including interviewing, hiring, reviewing, mentoring, career guidance, tasking, design and code reviews.
• Created Statements Of Work (SOWs) to be used as the basis for contracting activities, including budgeting and deliverables scheduling.
• Managed the Work Breakdown Structure (WBS) for definition and refinement of assignments, tasks and project timelines and deliverables for multi-million dollar funding effort directing team of 15 engineers.
• Designed, developed, tested and documented application for the XTCF (eXtensible Tactical C4I Framework) project funded by Office of Naval Research (ONR) in Java/J2EE. This was a revolutionary platform for integration of disparate systems that had not been done before.This system had significant QOS requirements for throughput, response time and availability.
• Designed, developed and integrated products covering complex system multi-level security.

Principle Lead Software Engineer

Predicate Logic Software Systems, Inc.,

Senior Software Engineer

AOL Time Warner

Marotz, Inc

Programmer/Analyst

ENGINEERING, RESEARCH & DEVELOPMENT, MANUFACTURING and QUALITY & REGULATORY LEADER | NAVY VETERAN
Champion of technology, engineering innovation, quality and compliance

Progressive leadership experience, responsibility and accountability at the VP level and above. Strategic driver of small to large global teams with strong track record of success.

Systems, Software, Electrical, Mechanical, Biomedical Engineering, Product/Project Management, Manufacturing  LEADER and executive with progressive leadership experience, responsibility and accountability at the VP level and above. Strategic driver of small to large global teams with strong track record of success in all aspects of complex systems integration, including software and hardware definition, design, implementation, support and maintenance of all system and wireless architectures

Quality and Regulatory LEADER and executive in the design, implementation, maintenance, and oversight of Quality Management Systems and compliance programs


CORE COMPETENCIES
Strong Integrity * Ownership & Accountability * Strategy & Vision * Product Development * Manufacturing * Outstanding Communication & Interpersonal Skills * Relationship/Culture Building * Global team building/development/management * Team mentoring & growth * Risk/Change Management & Mitigation * Budgeting * Champion of the right tool & Process for the job * System/Software Design and Development * Global Vendor Selection & Management * FDA * QSR * GMP * ISO 62304, 14971, 13485, 62366, 60601 * MDSAP

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