Paul Williams

La Jolla, CA – ***** – 619-***-**** – ac85g5@r.postjobfree.com – LinkedIn

Senior Project Management & Device Development Leader Engineering – Research & Development - Operations

Life Cycle Management

Root Cause Analysis

Product Development

Medical Devices

Business Development

Operations

Regulations Clearance

Manufacturing

Verification/Validation

ISO13485/cGMP

Analytical, multifaceted professional with extensive experience developing, deploying and evaluating medical devices aimed at improving quality of life and medical diagnostics.

Motivated by challenges and the opportunity to surmount goals and Company standards.

Strategic thinker, with the ability to define and articulate a clear tactical vision for R&D, product, and business development.

Strong technical expertise and comfort within Microsoft-based server environments, electronics, optics, sensors, mechanical design, software, manufacturing scale up, compliance testing, and clinical research.

Effective communicator skilled in building relationships across functions to drive organized operations; aptitude to convey complex concepts to stakeholders. CAREER ACCOMPLISHMENTS

• Project managed 5 startups through initial rounds of funding, FDA 510(k), and CE approval.

• Executed successful launch of Class II and Class III diagnostic/therapeutic medical devices.

• Developed a non-invasive diabetes screening device for primary care.

• Maintained key role in product development decision making, serving as subject matter expert in assessing potential products for likelihood of being patented.

• Played essential role in fundraising efforts for business and product development; raising over $15M for various projects.

PROFESSIONAL EXPERIENCE

DRS DAYLIGHT SOLUTIONS San Diego, CA 2019

Director, Engineering

Leading team that is developing a Mid-IR Laser Spectrometer for Pharma Process Control. This includes managing schedule, budget, setting performance metrics and assisting lead-customer development. Technical management includes Optics, Lasers, Fluidics, Systems Integration, Software, Mechanical and Electrical design, Compliance to 21CFRpart11 and CE.

FREEDOM MEDITECH San Diego, CA 2010 – 2019

Vice President, Research & Development

Successfully managed and maintained FDA (510(k)) and CE approvals. Obtained Series A-C financing for ClearPath products. Assisted in raising 10M in startup capital. Aided in the sell and merger of company to Sinocare.

• Product Development: Project managed and led development of the first non-invasive diabetes screening device for primary care (ClearPath).

• Project Management: Managed all aspects of new and existing projects; subcontracted engineering. Clinical, regulatory, and CMO to lessen financing requirements. Paul Williams

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OCULIR INC San Diego, CA 2004 – 2008

Vice President, Research & Development

Aided in raising 7M in startup capital. Served as company Cofounder. Project managed developed of non-invasive glucose device that measures glucose from the conjunctiva of the eye. Directed clinical studies; met project goals and standards within strict budget constraints. Successfully conveyed complex technology, project, and research findings to potential investors and stakeholders.

DEXCOM San Diego, CA 2001 – 2003

Sr. Director of Engineering

Head of Engineering for first 3-years of this start-up (now public) companies’ life. Directed a team of 18 in the development of a continuous glucose monitoring system (CGMS), wireless display device, and web interface. Aided the company in early animal studies, clinical studies and series A-C fundraising; resulting in FDA approval and $300M IPO. LXN CORP San Diego, CA 1997 – 2000

Director, Research& Development

Directed team of 15 Engineers, Scientists, outsource development and manufacturing partners to develop 3 FDA approved diabetes diagnostic products (Duet, InCharge, ExpressView). This included development of low-cost direct to consumer meter, Glucose and Fructosamine test strips, reagent controls, automated manufacturing equipment, clinical studies. ADDITIONAL EXPERIENCE

R&D Staff Engineer Integra Neuroscience, San Diego, CA Engineering Analyst NASA, Houston, TX

TECHNICAL PROFICIENCIES

Programming: C, C++, VB, PHP, SQL, MySQL

Software: Project, Office, Solidworks, AutoCAD, Cadence, Visual Studio, Matlab, LabView, Jira HW/Systems: Systems Design, Spectrometers, Fluorometers, Fluidics, Flow cells, Lasers, Optics, Fiber Optics, Vision Systems, Motion Control, POC Diagnostics, OTC Medical Devices, Reagents, Automation, Industrial Design, Plastics, Bio-Compatibility, Sterilization, Software, Clinical Studies, CE EDUCATION AND CERTIFICATIONS

OKLAHOMA STATE UNIVERSITY, Stillwater, OK

Master of Science, Mechanical Engineering

OKLAHOMA STATE UNIVERSITY, Stillwater, OK

Bachelor of Science, Mechanical Engineering

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