Kent Toepfer Email & Phone Number

Sun Prairie, Wi, Us

Madison, Wisconsin, United States

United States

• Led and managed departmental staff of eight full-time engineers, one contract engineer, and two interns; team consisted of product development engineers, mechanical engineers, and packaging engineers, with responsibility to develop and maintain new equipment to produce radioactive injectable drug called Technicium-99m, which included:o Designing and developing second-generation Technetium separation machine.o Product development of all consumable components needed to run Technetium… Show more • Led and managed departmental staff of eight full-time engineers, one contract engineer, and two interns; team consisted of product development engineers, mechanical engineers, and packaging engineers, with responsibility to develop and maintain new equipment to produce radioactive injectable drug called Technicium-99m, which included:o Designing and developing second-generation Technetium separation machine.o Product development of all consumable components needed to run Technetium separation machine.o Packaging of radioactive, caustic, and sterile components.• Developed and maintained $4M budget (excluding wages).• Created product road maps and project schedules; allocated resources to achieve road maps and other company priorities.• Met project staffing needs and developed resource planning tools to show department needs based on company priorities.• Set individual performance goals for team based off yearly company goals.• Initiated tools to ensure suppliers delivered consistent quality products: supplier change notification process, alternative suppliers, PPAP process, vendor-performed first article inspection process, and rewrote Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs) process. Show less

Department Management• Led and managed departmental staff of six engineers consisting of product development engineers, material science engineers, and packaging engineers to develop and maintain new pharmaceutical drug production components; team held responsibility for:o Material compatibility with drug product, ensuring no extractables or leachables got into final drug.o Maintenance and improvement of chromatography resins (ABEC and Alumina).o Product development of all… Show more Department Management• Led and managed departmental staff of six engineers consisting of product development engineers, material science engineers, and packaging engineers to develop and maintain new pharmaceutical drug production components; team held responsibility for:o Material compatibility with drug product, ensuring no extractables or leachables got into final drug.o Maintenance and improvement of chromatography resins (ABEC and Alumina).o Product development of all consumable components.o Packaging of radioactive, caustic, and sterile components.• Developed and maintained $1.8M budget (excluding wages).• Established and created materials compatibility group to fill company-wide void in development process.Sustaining• Conducted investigations into field failures and customer complaints. • Initiated mitigations and appropriate change documentation (i.e. CAPA, SCAR, NCMR, Deviations, DCO/ECO, etc.).• Implemented cost savings projects as part of yearly goals. • Worked to bring system reliability above company goal of 99.8%; used Pareto chart to determine which issue to address first.Product Development• Served as mentor to assist new hires develop plastic injection molded and plastic machined components to support future new product introductions and launches.• Conducted on-site supplier evaluations to establish new suppliers and ensure product quality. Show less

Madison, Wisconsin, United States

Leadership• Managed direct reports, consisting of product development engineer and packaging engineer, to develop and maintain new and existing pharmaceutical drug production components; team held responsibility for:o Product development of all consumable components.o Packaging of radioactive, caustic, and sterile components.Product Development• Led new product development for consumables used on NorthStar’s RadioGenix isotope separation system.• Developed machined… Show more Leadership• Managed direct reports, consisting of product development engineer and packaging engineer, to develop and maintain new and existing pharmaceutical drug production components; team held responsibility for:o Product development of all consumable components.o Packaging of radioactive, caustic, and sterile components.Product Development• Led new product development for consumables used on NorthStar’s RadioGenix isotope separation system.• Developed machined, injection-molded, and thermoformed plastic components to survive in highly caustic and radioactive environments.• Added package engineering position to new product development group to integrate packaging design/development into NorthStar’s consumables. • Developed project schedules, conducted phase-gate reviews, and prepared reports and presentations for senior management.• Held responsibility for financial goals of consumables product line and implemented 5-year cost strategy to bring costs down.• Implemented testing and analysis using statistical techniques such as binomial distribution, CPK, PPK, Six Sigma, standard deviation, etc.• Conducted DFMEAs and assisted manufacturing with PFMEAs.Sustaining• Led problem solving and cost reduction projects.• Utilized Fishbone and 5-Whys root cause analysis techniques. Show less

Madison, Wisconsin

Product Development• Developed plastic assemblies that withstood highly caustic and highly radioactive exposure.o Designed plastic component involving injection molding, machining, and thermoforming.o Used SolidWorks to analyze product design, create engineering drawings, and evaluate fit.o Performed plastic joining involving mechanical snaps, ultrasonic welding, and adhesives.• Developed components out of tungsten, lead, stainless steel, and depleted uranium (DU) to serve… Show more Product Development• Developed plastic assemblies that withstood highly caustic and highly radioactive exposure.o Designed plastic component involving injection molding, machining, and thermoforming.o Used SolidWorks to analyze product design, create engineering drawings, and evaluate fit.o Performed plastic joining involving mechanical snaps, ultrasonic welding, and adhesives.• Developed components out of tungsten, lead, stainless steel, and depleted uranium (DU) to serve as shielding from radiation. • Validated sterile assemblies by conducting: sterility validation (mostly VDmax25), dose mapping, package integrity, and stability/expiration testing.• Created and developed labeling for all components. • Conducted tolerance stack-up analysis on assemblies.• Conducted and participated in Design Review and Risk Assessment meetings. • Assessed Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs) for manufactured assemblies.• Implemented Engineering Change Orders (ECOs) by creating and conducting adequate product and/or process validation.Manufacturing• Developed manufacturing fixtures and processes that met FDA cGMP requirements.• Tested and validated equipment designs following DQ, IQ/OQ, PQ process.• Wrote work instructions and batch production records.• Gained experience working in ISO classified cleanrooms. Show less

Madison, Wisconsin

• Implemented company's first robotic milking machine for U.S. market.o Wrote robotic milking procedure for FDA approval.o Used SolidWorks to develop components.• Designed, developed, and tested products for Cow Traffic group.o Worked with marketing, quality, manufacturing, and purchasing to redesign heavy duty parallel cow stall.• Worked with exterior suppliers, manufacturing, and regulatory group to develop European-approved rubber formulation for teat cups.• Wrote and… Show more • Implemented company's first robotic milking machine for U.S. market.o Wrote robotic milking procedure for FDA approval.o Used SolidWorks to develop components.• Designed, developed, and tested products for Cow Traffic group.o Worked with marketing, quality, manufacturing, and purchasing to redesign heavy duty parallel cow stall.• Worked with exterior suppliers, manufacturing, and regulatory group to develop European-approved rubber formulation for teat cups.• Wrote and tracked Engineering Change Orders (ECO's).• Updated, reviewed, and evaluated engineering CAD files using SolidWorks. Show less

Reedsburg, Wi

Product Development• Performed engineering functions within team environment using established development template.o Worked collaboratively with team members from marketing, quality, manufacturing, and overseas sourcing offices.o Collected and compiled project’s financial information for cost analysis and team review.o Evaluated designs and prototypes for performance, manufacturability, and reliability.o Set up and implemented all necessary manufacturing tooling… Show more Product Development• Performed engineering functions within team environment using established development template.o Worked collaboratively with team members from marketing, quality, manufacturing, and overseas sourcing offices.o Collected and compiled project’s financial information for cost analysis and team review.o Evaluated designs and prototypes for performance, manufacturability, and reliability.o Set up and implemented all necessary manufacturing tooling, automation, and processes.o Maintained and updated project development histories, specifications, and schedules.• Created prototypes for evaluation and sales samples using FDM 3D printer.• Completed Engineering Change Requests (ECRs) for new product set-up, manufacturing changes, and specification updates.Project Management• Communicated weekly with Asian sourcing office and key overseas suppliers to coordinate audits, communicate design intent, ensure quality of production, and confirm timelines.Manufacturing• Developed rates, processes, and work instructions for use on shop floor.• Coordinated set-up, implementation, and training of new machinery and automation for individual projects.• Assisted in trouble shooting assembly equipment.• Met individual and company cost savings goal by reducing labor and/or material costs. Show less

Prairie Du Sac, Wi

Developed medical devices in accordance with ISO 13485 design and manufacturing directives. Used anthropometric data to design functional and comfortable devices. Served as key member in updating Product Life Cycle (PLC) process to map out how all departments will contribute to new product launch. Led all facets of project from start to finish including market research, setting design requirements/inputs (DFMEA, risk analysis, and timeline), verification testing, validation testing, packaging… Show more Developed medical devices in accordance with ISO 13485 design and manufacturing directives. Used anthropometric data to design functional and comfortable devices. Served as key member in updating Product Life Cycle (PLC) process to map out how all departments will contribute to new product launch. Led all facets of project from start to finish including market research, setting design requirements/inputs (DFMEA, risk analysis, and timeline), verification testing, validation testing, packaging, inspection criteria, technical specifications, SAP set-up (create part numbers and BOMs), transition plan, assembly instructions, etc. Show less

Reedsburg, Wi

Transitioned new product designs and enhancements into production, placing high priority on ergonomics and safety. Provided technical support to shop operations in areas of equipment, lay out, tools, fixtures, and machinery. Developed manufacturing equipment, fixtures, and work center layouts utilizing SolidWorks CAD software. Implemented new quality management system to align Gerber-Reedsburg facility with corporate quality requirements. Prepared project budget estimates which required… Show more Transitioned new product designs and enhancements into production, placing high priority on ergonomics and safety. Provided technical support to shop operations in areas of equipment, lay out, tools, fixtures, and machinery. Developed manufacturing equipment, fixtures, and work center layouts utilizing SolidWorks CAD software. Implemented new quality management system to align Gerber-Reedsburg facility with corporate quality requirements. Prepared project budget estimates which required frequent interaction with upper management, outside suppliers, and regulatory agencies to successfully complete projects. Show less