Todd Hill Email & Phone Number

San Diego, Ca, Us

San Diego, California, United States

San Diego Metropolitan Area

Lead engineer for the commissioning and qualification of equipment for 2 consumables from design to manufacture. Used CPM to characterize 8 different manufacturing processes for complex consumable assemblies.• Managed all tech transfer, and qualification efforts at CMOs in Singapore. Directed testing of processes including QC testers and GRR. Wrote and published engineering, CPM, and QC reports to support product launches.• Planned, implemented and analyzed DOEs to be executed by… Show more Lead engineer for the commissioning and qualification of equipment for 2 consumables from design to manufacture. Used CPM to characterize 8 different manufacturing processes for complex consumable assemblies.• Managed all tech transfer, and qualification efforts at CMOs in Singapore. Directed testing of processes including QC testers and GRR. Wrote and published engineering, CPM, and QC reports to support product launches.• Planned, implemented and analyzed DOEs to be executed by engineers in Singapore. Set specifications for 120 different parameters including Mass Flow, Pressure Decay, Torque, and angular position.• Developed testing methods using calibrated orifices to quantify sensitivity of QC testers for pressure decay (leak testing). Used method to determine the LOD/LOQ of 20 unique tests.• Assembled and managed team to down select AOI system to implement into manufacturing QC process. System was implemented to reduce cycle time of Air QC systems from 9 minutes per cycle to 30s. Show less

Madison, Wi

Engineering lead on consumable for a startup company introducing new technology for radioisotopes. Developed technology transfer supporting documentation, and integration of diagnostic products into aseptic fill/finish operations.• Procured, commissioned, and qualified a custom heat staking machine. Wrote and executed IQOQPQ protocols to qualify equipment to support company goal for FDA Submission of new RGX 1.2 system.• Supported implementation of eQMS system - Master Control. Served… Show more Engineering lead on consumable for a startup company introducing new technology for radioisotopes. Developed technology transfer supporting documentation, and integration of diagnostic products into aseptic fill/finish operations.• Procured, commissioned, and qualified a custom heat staking machine. Wrote and executed IQOQPQ protocols to qualify equipment to support company goal for FDA Submission of new RGX 1.2 system.• Supported implementation of eQMS system - Master Control. Served as primary contact and SME for QA and document control to troubleshoot and debug processes allowing the company to get ISO 13485 certification.• Worked closely with project management to develop tasks with realistic timelines to meet the demands of aggressive schedules.• Transferred processes from R&D lab in Madison, WI to new GMP manufacturing suite in Beloit, WI. Show less

Madison, Wisconsin

Contributed expertise to the design, assembly, debug, and delivery of custom automated machines to clients. Performed multiple client and vendor-facing duties including design reviews, BOM, and documentation deliverables.• Served as a key member in the kick-off to delivery of system with 9 different automated processes to launch medical device assembly used for DNA purification.• Optimized a heat stake process and streamlined cost by reducing the number of subsystem stations from 8 to… Show more Contributed expertise to the design, assembly, debug, and delivery of custom automated machines to clients. Performed multiple client and vendor-facing duties including design reviews, BOM, and documentation deliverables.• Served as a key member in the kick-off to delivery of system with 9 different automated processes to launch medical device assembly used for DNA purification.• Optimized a heat stake process and streamlined cost by reducing the number of subsystem stations from 8 to 2.• Led team to design and deliver an automated aseptic liquid filling and sealing system complete with documentation in 6 weeks. Allowing customers to meet schedule. • Commissioned and qualified a $2,000,000 system for assembly of 5 polystyrene parts. Wrote and led the execution of all test plans, and reports. The system had 9 liquid dispensing pumps, 110 pneumatic devices, 50 motors, and over 200 sensors including 5 inspection cameras. Show less

Los Angeles

Startup and Commission New Pharmaceutical Manufacturing Facility for Baxter

Member of engineering and maintenance team to support product finishing and manufacturing for all catalog and custom products. Contributed to the department’s crucial role in ensuring the company’s objective of no backorders.• Developed budgets and executed procurement, commissioning, and qualification of 10 capex projects resulting in increased manufacturing capacity and company revenue.• Applied quality engineering, statistics, and experimental design techniques to perform root cause… Show more Member of engineering and maintenance team to support product finishing and manufacturing for all catalog and custom products. Contributed to the department’s crucial role in ensuring the company’s objective of no backorders.• Developed budgets and executed procurement, commissioning, and qualification of 10 capex projects resulting in increased manufacturing capacity and company revenue.• Applied quality engineering, statistics, and experimental design techniques to perform root cause analysis for the resolution of chronic processing problems.• Served as lead engineer and subject matter expert for new product launch:o Led a cross-functional team to develop requirements for injection molded consumable parts for one of the company’s instruments. Designed part in SolidWorks and worked with Molder to build a 4-cavity mold.o Executed validation test strategies including shelf-life stability, sterilization validation, and extractable/leachable.o Designed and built the equipment to fill, seal, and label parts; developed timeline, and delivered on time/budget to complete the programming and other activities for the commissioning and qualification.o Designed and implemented additional capabilities to increase the throughput of the machine from 30 seconds to 15 seconds per cycle. Streamlined processes to increase shift output from 4,800 to 12,000 units.o All efforts supported product launch and FDA submission for 21 CFR parts 210, 211, and CE IVD marking. Show less

Madison, Wisconsin, United States

Collaborated with team of electrical, software and mechanical engineers as well as safety, quality, reliability and manufacturing teams to design and build Advanced Animal Habitat system prototype with 15 different subsystems. Lighting and Video Subsystem Lead Designer.• Designed prototypes, deliverable parts and assemblies for flight hardware• Wrote test plans and performed experiments to test and implement appropriate changes to design• Completed design of subsystem within design… Show more Collaborated with team of electrical, software and mechanical engineers as well as safety, quality, reliability and manufacturing teams to design and build Advanced Animal Habitat system prototype with 15 different subsystems. Lighting and Video Subsystem Lead Designer.• Designed prototypes, deliverable parts and assemblies for flight hardware• Wrote test plans and performed experiments to test and implement appropriate changes to design• Completed design of subsystem within design constraints - timeline, budget, mass and volume allocations Show less

Madison, Wisconsin, United States

Participated in cross-functional project teams in the development, optimization, transfer and validation of processes/products from lab to pilot scale for clinical trials.• Designed and assembled custom equipment containing pneumatics, PLCs, power supplies and relays• Developed methods to calibrate contact time, temperature, pressure and flow rate for validation• Documented procedures, test methods, results and conclusions of all work in formal reports and oral… Show more Participated in cross-functional project teams in the development, optimization, transfer and validation of processes/products from lab to pilot scale for clinical trials.• Designed and assembled custom equipment containing pneumatics, PLCs, power supplies and relays• Developed methods to calibrate contact time, temperature, pressure and flow rate for validation• Documented procedures, test methods, results and conclusions of all work in formal reports and oral presentations• Lead problem solving team for two patented processes• Update process equipment and documentation and incorporate new systems into the Clinical Manufacturing Area• Implemented ESD equipment into process to accelerate product filling rate by 20% and increased passing lot rate• Assisted with technical transfers for scale up of processes that progressed to Phase I Clinical Trials Show less

Bachelor Of Science (Bs), Biological Systems Engineering

Minor, Biochemistry