Sam Alexander

Research and development for development and sustaining engineering activities for medical products related to the treatment of Enteral Feeding, Thermometry, and Patient Care. The position activities include all phases of product life cycle management from early concept through end of product life, technical and project leadership regarding the project management, design, manufacture, testing, launch, post market surveillance, and complaints/corrective actions of the products in addition to working knowledge of regulations for the medical device industry. Responsibilities include: - Leads team of subject matter experts to lead projects as well as provide guidance on complex technical situations, assess impacts of key policies, regulations, standards and clinical practice for area of expertise and actively involved with staying current with, participating, and influencing those committees critical to the business - Designs research and development program proposals of advanced new applications to address unmet customer needs that may result in breakthrough or platform product/business opportunities - Organizes multiple resources, initiatives, and timelines with competing priorities to achieve team goals often with the need to manage contingency efforts in parallel while maintaining on-time project objectives and strategy execution - Technical lead/project manager for complex, cross-functional projects that provides precedent settings solutions and applies advanced knowledge and understanding of concepts, principles, and technical capabilities - Creates and provides inputs into new and existing process improvements and standard operating procedures for internal and cross-functional groups - Develops IP to support portfolio - Develops mentorship relationships and supports managing peer project efforts within and across cross-functional groups while promoting individual and business goal alignment and promoting continuous learning and innovation opportunities

- Technical lead and project manager for complex, cross-functional projects that provides precedent settings solutions and applies advanced knowledge and understanding of concepts, principles, and technical capabilities to manage a wide variety of projects. Projects are related to design change, complaint investigations, line extensions, maintenance, and new product development for the nutritional delivery, thermometry, and nursing care portfolios including but not exclusively syringe feeding pumps, feeding pumps, enteral access, enteral feeding, and syringe products lines ranging from NICU through adult patient populations. - Provides inputs into process improvements and standard operating procedure activities - Develops project objectives and executes strategies for projects - Develops IP to support devices and portfolio - Mentors colleagues and supports managing peer project efforts

Job profile included: - Technical lead and project manager for complex, cross-functional projects related to design change, complaint investigations, line extensions, maintenance, and new product development for the nutritional delivery, thermometry, and nursing care portfolios including but not exclusively syringe feeding pumps, feeding pumps, enteral access, enteral feeding, and syringe products lines ranging from NICU through adult patient populations. - Developed IP to support devices and portfolio - Developed innovative and organizationally support technical solutions to a variety of difficult problems. - Mentored colleagues in support of product and process initiatives - Received organizational C Speed Award for two projects highlighting achievement in accurate and efficient project execution

Job profile included: - Collaborated with cross-functional teams to develop and execute project plans for medical device development. - Worked closely with other departments to understand customer needs and develop product requirements. - Contributed to project to develop and implement product design control processes, including design inputs, outputs, verification, and validation. - Led initiatives and technically led within larger complex projects to execute deliverables provide solutions. - Developed and maintained relationships with key stakeholders, including suppliers, manufacturers, and regulatory agencies. - Ensured compliance with regulatory requirements and quality standards. - Identified and resolve project roadblocks by utilizing available resources and information. - Conducted research and stayed up to date on industry trends and advancements in technology. - Received organizational New Product Award as a part of the project team highlighting achievement in innovative new product development

Job profile included: - Collaborated with cross-functional teams to develop and execute project plans for medical device development. - Contributed to project to develop and implement product design control processes, including design inputs, outputs, verification, and validation. - Led initiatives within larger complex projects to execute deliverables provide solutions. - Identified and resolve project roadblocks by utilizing available resources and information. - Conducted research and stayed up to date on industry trends and advancements in technology.

Katecho is an internationally recognized, full service original equipment manufacturer (OEM) specializing in medical and cosmetic devices. - Develop original designs to improve cost efficiency and ability to manufacture while providing necessary documentation authentication and revision that comply with AAMI, ISO 13485:2003, ISO 10997:2009, ISO 14971, FDA Title 21 CFR parts 11, 211, 820, and ISO Pharmaceutical Certified - CFR 211 specifications. - Establish relationships with customers, vendors, and third party collaborators for customization and specification of introductory or existing products from executive level to engineering project members. Projects include EEG, EKG, defibrillators, custom hydrogel formulations, TENS, tDCS, application specific flexible circuits, as well as specialty medical devices. - Perform testing, prototyping, product design, process design, quality control remediation, and product development of the manufacturing of medical devices, tooling, and equipment. - Selected to develop an award-winning technology addressing prevalent medical concerns in the NICU as well as a technical liaison for an engineering initiative with an industry leader for custom product development. - Lead a collaborative effort of non-pharmaceutical/hydrating alternative for a chronic, common condition.

- Performed maintenance of tissue culture and technical assistance with tumor xenograft mouse models, specifically propagation of HT-29 colon cancer cells, tumor xenograft induction. - Performed ELISA assay and antibody purification following pegylation of viral nanoparticles in order to observe immunogenicity in mouse models.

Concentration: Tissue Engineering