David G. Allen, bseet, emba

*** * ******** **** **** • Boca Raton, FL 33432

acy9c9@r.postjobfree.com • 440-***-****

Executive Management

NPI • Continuous Improvement • Innovative Solutions • People/Systems/Process Development

Highly skilled and entrepreneurial-minded management professional with extensive history creating innovative, cutting-edge solutions to complex customer needs. Extensive experience in personnel management, process and product development, with proven business acumen backed by advanced education and track record of successful business leadership. Excellent communication and presentation skills; able to transform cross-functional staff into cohesive teams that continually exceed corporate expectations. Very hands-on mentoring people, developing processes and procedures, building, troubleshooting and validating hardware, software, test fixtures.

Over 30 years of business experience, 10+ years as a manager. Managed up to 4 divisions, 14 engineers, 11 technical and two maintenance personnel reports as Director of Engineering and Facilities. Experience with medical, aerospace, automation, contracting, manufacturing, R&D, customer focus, capital equipment, 2 patents 2 pending, innovation, invention, mentoring, managing, designing, quality, PDCA, GMP and more.

Operations and Management Strengths:

•Possess Integrity

•Product Design & Prototyping

•Innovation and Improvement

•Sales & Marketing Direction

•Superior work ethic

•Process / Procedure Engineering

•Accomplished Public Speaker

•Team Building, Training & Mentoring

•Program and Project Management

•New Product Introduction (NPI)

•Key Client Relationships

•Conflict Resolution

•Technical Documentation

•Worked across international boarders

Professional Experience

ACR Electronics– Fort Lauderdale, FL November 2014 to Present

Operations Program Manager

Responsible for New Product Introduction (NPI) and maintaining engineering support for an existing product lines of radio frequency safety beacons used on military and commercial aircrafts, ships, boats and personal locator beacons, based on GPS and 406 MHz broadcast technology. Responsible for Component Engineering and Continuous Engineering when it applies to obsolescence issues. Also responsible for designing and implementing jigs and fixtures, recommending a Manufacturing Execution System (MES) solution, developing operational structures, processes, SOPs, Process Readiness Reviews, product cost reduction and their implementations and other projects as required.

Wired, Incorporated – Willoughby, Ohio August 2013 to Nov 2014

Founder and President

Wired Incorporated is a contract consulting firm founded by myself in 1994 and dedicated to supporting businesses in need of managerial and technical oversight. A contract was accepted for the following position

Director of Engineering and Quality – Highland Heights, Ohio

Manage the efforts of Engineering and Quality groups involved in the design and manufacturing of fiber optic transceivers for the aeronautics industry. Developed processes and procedures to manage Production and Quality.

A cGMP quality program was put in place

Fixtures were created which increased productivity by 25%.

Libra Industries – Mentor, Ohio July 2010 to August 2013

Printed Circuit Board Contract Assembly House

Director of Engineering and Facilities

Manage the efforts of three separate engineering groups, Component Engineering, Manufacturing Engineering, and Test Engineering as well as Facilities Management, for an electronics contract manufacturer. Assembled a team of highly skilled individuals managing all aspects of the manufacturing environment, work closely with the production manager, CFO and COO on velocity, on-time-delivery, NPI turnaround and efficiency metrics. Responsible for hiring, training, development and removal of Associates based on performance and business conditions.

Selected Contributions:

Proposed, purchased, scheduled and installed capital equipment

Designed multiple processes and fixtures reducing labor hours, increasing safety and saving money

Met with customers regularly in order to be certain we met their needs on a daily basis

Re-Structured and implemented the New Product Introduction (NPI) process

Wrote Work Instructions, Process Sheets, IT implementation protocol, Department Plans, Budgets, etc.

Public speaking engagement, “Types of Conformal Coating, Applications and Process Issue Mitigation” based on published white paper of same name

Hosted webinars on the topic of Conformal Coating

Acquired Certified IPC Specialist Certification- CIT

Personally performed assembly, test and troubleshooting processes prior to documenting and integrating

Designed and implemented new Conformal Coating room

Managed all facility repair, modification and maintenance

Wired, Incorporated – Willoughby, Ohio March 2007 to July 2014

Founder and President

Wired Incorporated is a contract consulting firm founded by myself in 1994 and dedicated to supporting businesses in need of managerial and technical oversight.

Contracted company overview:

Omnitek – Beachwood, Ohio Startup, Contract

Project Manager and Design Engineer

Coordinate multiple projects for electrical engineering contracting firm. This is a hands on position that requires the performance of R&D, scheduling, time tracking on a per project basis, customer relations, contract acquisition, quality control, procedure development, design for manufacture to name a few.

Selected Contributions:

Implemented cGMP based FDA quality control program.

Designed, built and tested biorhythm sensor for medical, civil, and DOD applications

Coordinated design, development and manufacturing efforts for multiple projects using MS Project

Manage engineering teams involved in 5 separate projects

Designed and presented proprietary heart monitoring sensor to customer and board of investors

NovaSterilis – Lansing, New York Startup, Contract

VP of Engineering and Manufacturing

Manage technical operations for a company that provides an innovative technology and system for deep tissue sterilization. This sterilization system works on the principle of using supercritical CO2 as a transfer media for a proprietary additive.

Coordinate purchasing, assembly, testing, and national installation efforts and customer support; develop policies, procedures and system manuals, train and coordinate technical teams driving product innovation, development, and implementation. Interface frequently with customers and vendors to resolve performance issues, improve product functionality to ensure complete satisfaction with product and services.

Selected Contributions:

Developed and implemented quality control program based on cGMP

Work with professors from Cornell University on system development

Re-designed, built and tested system for manufacturability in compliance for 510K submission

Write and review grant proposals

Managed, mentored, two direct reports in design, assembly, quality, innovations, and manufacturing

Implemented and enforced safety procedures and policies

Researched and made recommendation on how to detect concentration of sterilant within the vacuum chamber

Preparation for 510K submission

VeriShot – Solon, Ohio Startup, Contract

Director of Operations

Managed technical operations for start-up company providing unique monitoring technology. Actively participate in all aspects of business, driving enhancement and delivery of automated system that harnesses solar-powered video monitoring, wireless technology, and touch-screen applications to provide clients with innovative method for conducting hole-in-one, closest-to-pin, and related contests to boost golf course revenue. Lead purchasing, assembly, testing, and national installation efforts; develop policies, procedures and system manuals, train and coordinate technical teams, and drove product innovation development and implementation. Interface frequently with customers and vendors to resolve performance issues, improve product functionality and ensure complete satisfaction with product and services.

Selected Contributions:

Direct role in generating revenue increase of 43% within four months of hire, and 66% within the first year.

Evaluated and redesigned system components to create more robust, higher quality and vandal-resistant product; expanded market share more than 50% while slashing system costs by 30%.

Brought system redesign, integration and implementation to market three months ahead of schedule.

Raised department productivity through institution of efficient procedures for assembly, installation, repair and safety.

Managed four direct reports in design, installation, maintenance

Created installation methodology significantly improving safety and efficiency

Personally performed every installation with the assistance of a technician

STERIS Corporation – Mentor, Ohio February 2003 to March 2007

Lead Engineer

Skillfully coordinated efforts of multiple cross-functional teams, driving development and improvement of medical equipment as lead technical interface. Managed schedules and resources, and championed new idea generation, capture, ranking and implementation as Innovation Forum Team Leader.

Selected Contributions:

Worked with customers, Doctors and Nurses, on new product development

Moderated Engineering ideation process called Innovation Forum, a 12 engineer Think Tank

Approved as and performed FDA IEC 601-1 In-house testing on operating room LED surgical lighting

Managed major development initiatives, consistently meeting all key project milestones; brought new LED surgical lighting system to market on time and on budget.

Conceived and implemented modularized software approach widely accepted throughout organization, saving company thousands of development hours and substantially reducing time-to-market.

Spoke at Engineering Conference on the topic of Remote Servicing Implementation.

Accomplished public speaker; authored several well-received technical papers, and earned invitation to deliver presentation at major medical symposium in Spain.

Engineer, Controls and Automation

Played integral role in design and implementation of new medical equipment products and improvements as team member, and served as project coordinator on initiatives to reengineer establish products to drive cost reduction and resolve obsolescence issues. Developed and reviewed documentation to ISO, IEC, FDA and cGMP standards.

Selected Contributions:

Developed and patented medical device efficacy sensors, patents, #6,897,661 and #6,930,493, improving product effectiveness and efficiency, adding value and differentiation to product line.

Opened up new sales areas by instituting 2-byte, multi-language printing, generating profits projected at $800M; efforts included development of new product for printer driver vendor Kepware, and added capabilities that Rockwell, Siemens and other PLC manufacturers lacked.

Drove Remote Servicing and RFID to project status level, projected to deliver combined profits of $9.7M.

Actively involved in advanced robotics development of 6-axis arm and autonomous vehicle, positioning company for potential new product offering.

Through collaborative efforts with STERIS Switzerland, brought new High Level Disinfector project to completion on time and under budget.

Performed extensive testing on active RFID tag implementation and reading of surgical instrumentation

Managed project implementation based on IEC13485

Oversaw and supported 510K product development, submission and testing

Education and Credentials

Executive Master of Business Administration (EMBA)

Bachelor of Science in Electrical Engineering Technology (BSEET) – Graduated with Honors

Cleveland State University – Cleveland, Ohio

Professional Development

•Dale Carnegie Change Management Course

•cGMP Certificate of Completion

•Human Factors Training

•Industrial Controls and ISO Specifications

•NASA Soldering Standards Certification

•Certified ORCAD Designer

•Solidworks

•Motoman NX100, 6-axis Robotic Arm Programming Certification

•SLC 500 PLC and RSView HMI Programming

•IPC CIT

•Published technical article

•AutoCAD LT

Professional Associations

Institute of Electrical and Electronics Engineers (IEEE) Member

Golden Key International Honor Society Member

Former Lake County YMCA Board of Managers Member

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