R D Product Development
Resume:
Kestas “Kes” Parakininkas
Englewood Colorado
ad5o3d@r.postjobfree.com
R&D Experience
Specialized in concept development and de-risking, capturing and documenting Voice of the Customer, defining user needs and product requirements, and drafting Lower-Level Requirements (LLRs). Proficient in CAD for design and development, adept at presenting to large audiences, and highly knowledgeable in various molding technologies. Experienced in creating Cost of Goods (COGs) estimates, applying phase-gate development methodologies, and collaborating with regulatory teams for FDA compliance. Utilized Design for Manufacturing
(DFM) principles, with extensive expertise in machining and manufacturing processes. Skilled in developing and implementing Design Verifications & Test Method Validation (TMV) protocols. Effective mentor to junior engineers and excels in cross-functional team collaboration. Worked and collaborated with contract and mold manufacturers to develop new components and subassemblies that were inexpensive and easy to supply. Very familiar with ISO 13485, 21 CFR as well as ISO Standards both mechanical and biological as it relates to product development and testing.
EXPERIENCE
Terumo BCT (Lakewood CO): March 2012 – March 2024
2017 – 2024; Senior R&D Engineer: Led a team in the government-funded Freeze-Dried Plasma (FDP) initiative, successfully transitioning from feasibility to development. Directed a small group of R&D engineers and technicians in creating and de-risking a prototype disposable and process for safe transfusion. This work secured additional funding and resulted in the design, documentation, and verification of a novel Pooled Disposable Set and lyophilization process, earning 4 patents with 3 pending. Collaborated with a diverse cross-functional team including project management, engineering, and marketing to achieve project milestones.
FDP Project Experience and Core Competencies
o Established voice of the customer documentation
o Developed User Needs documentation
o Developed Product Requirements Document (PRD) and Lower-Level Requirements (LLR’s) o Worked with human factors team to develop formative & summative protocols for development and Design Verification
o Developed & executed testing protocols for Design Verification o Developed Test Method Validation (TMV’s) to support testing data for specialized testing o Directed junior and senior engineers toward design and developmental goals o Work closely with Design Quality
o Helped develop and establish risk assessment documentation o Helped develop and establish design Failure Mode & Effects Analysis (dFMEA) and use Failure Mode & Effects Analysis (uFMEA)
o Wrote and presented monthly reports about accomplishments for the project o Worked with development operations engineering to produce a pilot line to build disposables for Design Verification and first in human use
o Established Design for Manufacture (DFM) meetings with development operations engineering o Worked with Regulatory on requirements for the FDA to achieve First in Human Use (FHU) for dose escalation trials
o Used extensive knowledge of Machining, Molding and 3D printing to develop new prototypes rapidly. Worked with contract manufacturers to develop new subassemblies and components. 2013 – 2017; Promoted to R&D Engineer 3: With a team of R&D Engineers explored the feasibility of developing a platform to reduce the amount of time to treat a unit of whole blood from 65 minutes to 30 minutes or less for the Mirasol Product line. Terumo BCT’s Pathogen Reduction Technology (PRT) that inactivates pathogens in blood products. Reduced treatment time from 65 minutes to 40 minutes while dramatically improving the blood quality. Reduced cost of the equipment from $30,000 to manufacture the equipment to an estimated COG’s and overhead of $5,000. While not achieve the 30 minute treatment due to disposable bag size constraints, a new platform to treat more than one unit at a time was designed and built reducing the blood treatment down to 15 minutes per unit.
R&D Engineer Experience and Core Competencies
o Research new emerging technologies
o Designed experiments to troubleshoot mixing issues o Excellent skills to relate complex issues in easy-to-understand presentations o Proficient at using Siemens NX Cad Software
o Extensive knowledge of machining and molding experience to work with machinists o Light transmittance SME
o Developed a high speed industrial spectroradiometer to read light transmittance and produce a real-time value during production of the vinyl for the disposable o Identified inconsistencies of the disposable vinyl production at the manufacturer 2012 – 2013; Manufacturing Engineer 3: Managed COBE 2991 Disposable manufacturing. Identified and integrated a replacement ceramic bearing to avoid a complete manufacturing shutdown. Moved, developed and integrated a newly acquired disposable into the Lakewood Colorado cleanroom called TACSI. Developed a new method of applying super glue for tubing connections on the TACSI line. Worked with outside suppliers and contract manufacturers to supply sub-assemblies as well as helped them validate there production lines. Orthofix Inc (Frisco TX): Jan 2006 to March 2012
2008 – 2012; R&D Manufacturing Engineer: Worked with R&D using Design for Manufacture (DFM) principles and used my extensive knowledge of machining and injection molding on projects that were being developed. Implemented SolidWorks Enterprise software to manage SolidWorks & engineering documents to maintain design traceability of new and old product documents. 2006 – 2008; Manufacturing Engineer: transferred the Intramedullary Skeletal Kinetic Distraction (ISKD) Lengthener product line to be built in house at Orthofix Inc in Texas. COBE Cardiovascular/Sorin (Arvada CO): May 2002 to Dec 2006 2004 – 2006; R&D Manufacturing Engineer: helped develop the Angel Platform (Platelet Rich Plasma Production Platform from whole blood)
2002 – 2004; Development Manufacturing Engineer: developed new assembly processes to improve the quality and speed of production lines. Worked with contract manufacturers to improve sub-assembly manufacturability. May 2002 – Sep. 2002; Contract Manufacturing Engineer: Assisted with production issues in cleanrooms. CBW Automation (Ft Collin CO): December 2000 – March 2002 Project Engineer (Contract)
Bausch & Lomb Surgical (Clearwater FL): June 1999 – December 2000 Manufacturing Engineer (Contract)
Sherwood Medical/Kendall Medical (Deland FL): August 1998 – May 1999 OEM Development Engineer (Contract)
EDUCATION: UI Chicago, Illinois. Degree in Mechanical Engineering: BSME
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