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With over 20 years in engineering and operations, my journey has spanned medical technology, international business operations, product development, and consulting. My focus is on leading operational turnarounds and strategic initiatives, constantly seeking ways to enhance efficiency, productivity, and profitability in every role. My approach combines a deep understanding of financial modeling, cost analysis, quality systems, budgeting, and process validation, using these tools to bring clarity and solutions to problems that plague Medical Device and Biotechnology businesses.My unique combination of skills and education has led me to spearhead significant projects and initiatives, each presenting unique challenges and learning opportunities. From leading a major project in Salzburg, Austria, to turning around operations at a critical juncture, my experiences have been diverse. These roles have required a blend of strategic thinking, hands-on problem-solving, and the ability to adapt quickly to changing environments. As the Founder and President of i3MedTech LLC, I have extended my expertise to a broader range of clients, from startups to established firms. This role allows me to provide tailored consulting services, focusing on the unique challenges and opportunities within the biotechnology and medical device sectors. It’s a position that demands constant learning and adaptation, and I embrace these challenges, driven by the knowledge that the work I do has a tangible impact on patients, businesses, and the industry as a whole.People enjoy working with me because I value cross-functional input and collaborate to co-create a whole that is greater than the sum of the parts: synergy. And I have a sense of humor and keep things fun!I see things in systems, so I integrate information from diverse sources to address systemic problems rather than a single-dimensional solution for others to integrate.✦ Strategic leadership (recognizing and prioritizing strategic opportunities and problems).✦ Team development and leadership✦ Medical technology operations and quality management✦ Technical process development/management/improvements✦ Efficient use of quality systems in operationsLEADERSHIP PHILOSOPHYLeadership rooted in integrity fosters a respectful, humble, and communicative culture. Collaboration is key to creating comprehensive solutions and ensuring team engagement.
I3Medtech
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PresidentI3Medtech Dec 2019 - PresentAs Founder and President, I provide consulting services in strategy, lean process development, and engineering within the biotechnology and medical device sectors. My work involves guiding companies through crucial phases such as top leadership transitions, post-FDA clearance operations, supplier relationship management, and initial revenue generation strategies. My expertise spans R&D team leadership, operational strategy, infrastructure planning, and resolving vendor conflicts, catering to a diverse client base from startups to established firms.At PhotonPharma Inc. (photonpharmaceuticals.com), in my role as Fractional Vice President of Operations, I've revitalized the operations of a therapeutic solid tumor vaccine developer. This involved rewriting business plan and fundraising information, securing vital funding, and managing business systems across the company. More recently, I'm establishing their Quality Systems and the company prepares for and enters phase 1 clinical trials. My efforts are contributing to the development of a groundbreaking therapeutic cancer vaccine..
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Chief Operating OfficerColorado Therapeutics Llc Jul 2018 - Nov 2019Louisville, Co, UsColorado Therapeutics brings a new perspective to developing and commercializing innovative products for a broad range of soft tissue repair, reinforcement, and regenerative applications. -
Acting Chief Operating OfficerColibri Heart Valve Jul 2018 - Nov 2019The Colibri TAVI System is the only transfemoral aortic heart valve that is pre-mounted, crimped, andloaded at manufacture. -
Chief Operating OfficerIncubar Llc Jun 2017 - Nov 2019Incubar is a medical device incubator for technologies intended to address unmet patient needs.
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Vice President Of OperationsEncision Inc. Mar 2014 - Mar 2017Boulder, Colorado, UsI oversaw a range of critical functions including purchasing, receiving, manufacturing, engineering, shipping, and facilities. My focus was on streamlining these operations to enhance overall efficiency and effectiveness. This involved rethinking traditional processes, implementing innovative practices, and ensuring that every aspect of operations worked seamlessly together.One key strategy was to improve manufacturing quality and efficiency. This involved redesigning products for better manufacturability, reducing unnecessary parts, defining quality criteria and refining the manufacturing process. Additionally, I prioritized optimizing equipment and processes, which resulted in a marked improvement in quality control, contributing to the overall operational success of the organization.Additionally, I prioritized inventory management practices. By transitioning from manual methods to more sophisticated systems, and was able to significantly streamline inventory processes. This shift not only optimized inventory management but also positively impacted manufacturing and shipping operations. -
Executive Director Of ManufacturingLightdeck Diagnostics (Prev Mbio Diagnostics) Apr 2013 - Mar 2014In this role, I was part of a five-person executive team focused on developing and launching a Point-of-Care (POC) CD4 Cell-counting system for HIV monitoring, along with other diagnostic products for emerging markets. This role required not only technical expertise but also a deep understanding of the unique challenges and opportunities in these markets.Upon joining the company, one of our first tasks was to achieve ISO13485 Medical Device Manufacturing Certification. This was particularly challenging as the starting point was a prior failed audit, and the team largely consisted of staff with academic backgrounds and limited regulatory experience. Through dedicated leadership and strategic guidance, we successfully navigated the team to certification within a remarkably short timeframe.In addition to certification, my role involved developing the manufacturing and operations infrastructure necessary for the forecasted launch of the CD4 system. This was a multifaceted endeavor, as it required balancing the production of the CD4 system with the ongoing manufacturing of multiplex fluorescence immunoassay systems used in various global health studies. This role demanded careful planning, coordination, and execution to ensure all projects progressed efficiently and met their respective goals.
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PrincipalOculus Engineering Llc Jun 2011 - Jan 2013Medical device consulting ranging from start-ups to established design and manufacturing firms. Consulting services include business strategy, design for manufacturing and assembly, medical device process validation strategy and execution, manufacturing process optimization, product design for manufacturing, automation design and medical device operations.
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Program Manager, Project Manager, Sr. EngineerBaxa Corporation (Currently Baxter Healthcare) Nov 2000 - Feb 2011Deerfield, Illinois, UsWhile at Baxa, I spearheaded $15M product line redesign in Colorado corresponding high-speed automation project in Salzburg, Austria. I split my time between Englewood and Europe, eventually moving my family to Salzburg to accelerate completion of the automation. The multi-year project forecasted EBITDA $5.7M return in first 12-months post-implementation. A critical strategy after validating the automation process in Englewood was rapid improvement in Overall Equipment Efficiency (OEE). I generated a business model, integrating material consumption, process times, scrap rates and machine times into financial proformas, to enable quick financial prioritization of projects to accelerate the company learning curve. This effort doubled the automation OEE in the first 5 months of production, translating to another $650,000 improvement to the annual financials.In addition, I discovered and solved manufacturing inefficiencies on other product lines, including annualized $1.03M reduction in production labor through designing for quality rather than inspecting for failures, and replacing archaic bulk oral syringe packaging automation, resulting in $500k in oral syringe savings through accurate product counts and generated a company-wide Process Validation system to validate and monitor ongoing compliance.Recognized in Baxa’s 2009/2010 CEO Challenge as top 1.5% of employees and rewarded for exceptional performance. Awarded “Dolphin Award” in 2007 for exceptional leadership among cross-functional teams. -
Product Manager, Manufacturing EngineerGambro Bct (Currently Terumo Bct) Dec 1996 - Nov 2000Managed the Spectra disposable operations technical staff in Lakewood, Colorado, USA and supported the technical staff in Gloucester England, driving alignment with corporate initiatives of increasing production efficiency and product quality, while reducing operational costs. Delivered significant annual savings by redesigning the tubing configuration in apheresis disposables. Received the Corporate Achievement Award for outstanding performance.
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Engineering PracticantAudi Ag Jun 1996 - Dec 1996Ingolstadt, Bayern, DeQuality control engineering. Vendor audits. Spare tire tray material testing for the Audi TT initial product release. All work conducted in German. -
Engineering InternGambro Bct (Currently Terumo Bct) Mar 1995 - May 1996Participated in a controls system redesign for the BIER vessel (Biological Indicator Evaluation Resistometer), used for Ethylene Oxide (EtO) sterilization cycle development. Developed and validated prototype EtO sterilization cycles, ultimately used in newly designed production EtO sterilization chambers.Developed product out-gassing profiles for apheresis disposables sterilized in new production EtO chambers.Participated in a controls system redesign for laboratory Autoclave.
Valerie Ray Dba, Msme, Pmp Skills
Valerie Ray Dba, Msme, Pmp Education Details
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Drexel University'S Lebow College Of BusinessRegulations And Field Quality In The Medical Technology Industry -
University Of Colorado BoulderBioengineering
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University Of Denver - Daniels College Of BusinessMaster Of Business Administration (M.B.A.)
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University Of Colorado DenverMechanical Engineering
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Johannes Brahms Gymnasium, Hamburg GermanyAll Work In German. German History And German Language
Frequently Asked Questions about Valerie Ray Dba, Msme, Pmp
What company does Valerie Ray Dba, Msme, Pmp work for?
Valerie Ray Dba, Msme, Pmp works for I3medtech
What is Valerie Ray Dba, Msme, Pmp's role at the current company?
Valerie Ray Dba, Msme, Pmp's current role is Medtech Executive | Medical Devices & Biotech | Innovation Management | Quality Systems | Lean Methods | Top&Bottom-Line Growth | High Performance Teams | Strategic Vision and Implementation | Supply Chain Mgmt.
What is Valerie Ray Dba, Msme, Pmp's email address?
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What is Valerie Ray Dba, Msme, Pmp's direct phone number?
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What schools did Valerie Ray Dba, Msme, Pmp attend?
Valerie Ray Dba, Msme, Pmp attended Drexel University's Lebow College Of Business, University Of Colorado Boulder, University Of Denver - Daniels College Of Business, University Of Colorado Denver, Johannes Brahms Gymnasium, Hamburg Germany.
What skills is Valerie Ray Dba, Msme, Pmp known for?
Valerie Ray Dba, Msme, Pmp has skills like Cross Functional Team Leadership, Medical Devices, Fda, Lean Manufacturing, Iso 13485, Six Sigma, Project Management, Program Management, Management, Validation, Continuous Improvement, Engineering.
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