Tom Tylutki Email & Phone Number

Edison, Nj

• Functioning as the lead technical engineer responsible for the strategic development and commercialization of a novel acellular, adipose-derived tissue graft for use in aesthetic and wound healing applications.• Directed a business unit consisting of sixteen cross-functional team members in order to optimize revenue and achieve marketing, financial, and corporate growth objectives.• Developed and implemented a tactical meeting format centered on driving project initiatives associated with key performance indicators. Facilitated the alignment and prioritization of business unit goals with overarching franchise strategy.

Edison, Nj

• Drive continuous improvement initiatives for adipose-derived tissue graft in order to support scale-up activities and forecast growth. Efforts have resulted in a 160% increase in donor tissue eligibility, a 62% decrease in failure rates, a 25% increase in product yield, and a 21% overall increase in process efficiency.• Lead an interdepartmental technical team in the conception of project initiatives including continuous improvement activities, line extension opportunities, and new product ideations.• Design, execute, and report on mechanical and biochemical characterization studies in order to ascertain regulatory classification of an adipose-derived tissue graft via FDA pre-RFD submission.• Collaborate with CROs and academic laboratories to design and execute dose response and product stability pre-clinical studies for injectable tissue grafts.• Drive the development and optimization of an injectable adipose-derived tissue graft in order to maximize use of donated tissues and improve clinical outcomes in general and aesthetic surgical applications. Efforts resulted in an estimated 200% average yield increase, halving of overall processing time, and reduced production costs.• Conduct pilot experiments leading to process improvements for the production of acellular dermal grafts following root cause analysis. Implemented process controls resulted in a 74% reduction in related customer complaints.• Co-developed a novel cutting device and process to facilitate point-of-care customization of meniscus grafts for use in osteoarthritic interphalangeal joint repair in the proximal hand.• Designed and executed verification and validation studies to expedite the transfer of a placenta-derived tissue graft from R&D benchtop scale to the commercial production environment.• Planned and executed IQ/OQ and GR&R studies to qualify existing and prototype equipment for routine use in the characterization and/or production of new or existing tissue grafts.

Edison, Nj

• Planned and executed design of experiment (DOE) activities to verify product and process specifications.• Generated technical summary reports from collected data and presented conclusions to project teams, management, and clientele.• Collaborated with project teams to transfer benchtop products and processes to the manufacturing environment by heading various training, documentation, and validation initiatives.• Researched and assessed innovative product characterization methods and equipment to improve product performance.• Contributed to Kaizen Blitz events and CAPA Investigations geared toward facilitating company-wide improvement.

Bridgewater, Nj

• Performed laboratory testing to demonstrate ability of product/device to function as intended (validation and verification of process)• Monitored the performance of processes and equipment in order to make recommendations for continuing improvement• Coordinated with in-house manufacturing group to scale up, validate, and transfer the commercial manufacturing process• Inspected and maintained inventory levels for items and equipment within the laboratory• Trained to cGDP, cGTP and cGMP as well as aseptic tissue handling and processing

Newark, Nj

•Developed Learning Objects which enabled high school teachers to effectively implement robotically performed mock-medical surgeries into their class curricula.•Assisted in the adaptation of the aforementioned Learning Objects into various programming and mock-surgery design tutorials which would be integrated into an online, nation-wide database.•Supervised and assisted the progress of over 50 teachers spanning six states as they advanced through the program.•Co-Author: Integration of Medicine and Robotics – an online teacher professional development program for STEM education; ASEE Annual Conference & Exposition, 2013

Master Of Business Administration - Mba, Business Administration, Management And Operations

Master Of Science, Biomedical Engineering, 4.0

Bachelor Of Science, Biomedical Engineering, 3.8

Activities and Societies: NJIT BMES, NJIT BMEHS, Tau Beta Pi - NJ Gamma, Delta Epsilon Iota, Phi Eta Sigma, Albert Dorman's Honor College•.

Education record