Jon Larsen Email and Phone Number

 Global Integrated Engineering (GIE) program manager for new product development, product or process design changes, and high capital spend programs within the BD medical device business segment. o Leading multiple, multi-disciplinary engineering teams through the industrialization process for new large capital equipment, retrofits, and molding.

Core team member - manufacturing technology innovation, for multiple new product development and sustaining projects. My team is the link from product development (R&D) to full scale production (Ops). o Successful early launch of new SafeScrub product (NPI) despite the Covid pandemic supply chain delays. o Leading multiple teams of Assembly Automation, Process Development, and Molding Engineers across 5 states and 4 countries in product design for manufacturability (DFM), industrialization and production planning. o My team is responsible for production/mold equipment specifications (URS), quoting and PO generation, equipment design review, proof of concept testing, process development, equipment acceptance (FAT/SAT), work instructions, and process validation.  I manage schedules, team meetings and deliverables, expense and capital budgets, stakeholder communications, validation planning, product design feedback, and all other team leadership responsibilities, as well as individual responsibilities for select equipment. o Developed: DFM risk retirement plans, industrialization strategies, detailed capital spending plans, COGs, process improvement and development plans, resource planning, and validation plans

-Our team developed training in DFM(A) to help engineers design parts and products that are more easily manufactured and assembled.− New Product Developmento Participated in dozens of design reviews for multiple pieces of multi-million-dollar capital equipment.o Project lead for process development team on high volume automation launch of international multimillion-dollar medical device project.o Core team member of a cross functional team with R&D, Quality etc for large scale new product development (NPD) and launch (NPI).o Developed new vendor communication and specification documentation to communicate product and equipment specifications more effectively to vendors during capital equipment acquisition.− Sustaining Engineering, Cost Improvements, Line Modificationso Regularly asked to consult or travel to other facilities to troubleshoot issues and provide a recommended path forward.o Developed process windows for equipment ranging from lab and proof of principle, up to full-scale high-volume automation.− Developed new process and assembly technologies (DOE), tooling and fixture designs, validated equipment (IQ/OQ/PQ), built timelines, URS requirements, assembly steps and sequences (Process Flow), process journals.− Majority of my projects are not local; therefore, I work and coordinate regularly with multi-disciplinary teams both throughout the nation, and internationally.

- Project lead for R&D lab and pilot line planning and setup at new facility. - Responsible for layout and utilities planning, work and material flows, timelines, equipment specifications (URS), equipment quotations and POs, vendor coordination and management, installation, process development and validations.- Also responsible for design control documentation including design development plan and design verification planning for new combo medical and pharmaceutical product.

- Two patents for Anti-Run-Dry IV sets, and suspension or stopping of a fluid column with a porous membrane.- Led efforts for developing a design verification strategy and test procedures for our new product.- In addition to my regular job of designing, building, and testing prototypes I created several novel test fixtures that allowed simple and accurate testing of important design elements that had not previously been addressed. I also improved on current methods. I trained and supervised engineering technicians on test methods and test fixtures.- I was a key contributor in developing a critical process step, for assembly of a new product.- My strong technical writing skills allowed me to clearly present information through test protocols, engineering studies, memos, and MSA’s; this kept all members of the team up to date on the current data.

- Led several multi-disciplinary teams targeting process improvements, developed project plans and risk assessment/management plans, organized weekly cross-functional team meetings which kept the projects ahead of the scheduled timeline.