David De Renzy Email & Phone Number

San Diego, California, United States

San Diego, California, United States

San Diego, California, United States

• Led and supported multiple New Product Development and Sustaining Engineering projects forWorldwide Infusion Preparation & Delivery portfolio with hundreds of product lines, thousands ofproduct SKUs. In addition, drove functional excellence and best practices in areas of Design Inputs,Risk Management and Design Verification.

San Francisco Bay Area

• Designed and developed manufacturing and test processes for a sublingual therapeutics start-up.• Established production space and acquired necessary equipment for manufacturing and testing.• Developed requirements, collected data, drove design decisions, and tracked & managed risks.• Developed cost model to support product pricing and business development strategy.

San Diego, Ca

• Systems Engineering Lead for the next generation Continuous Glucose Monitoring System (G7)while establishing SE infrastructure and discipline with new tools, methodologies anddocumentation practices.• Facilitated integration of multidisciplinary technologies by sharing technical knowledge and visionwith cross-functional teams (Mechanical, Electrical, E-chem, Membrane, Software & Algorithm).Drove alignment among key stakeholders by defining product development scope, direction, targetsand risks using Technology Investment Proposals, Product Concept Plans and competitive analyses.Facilitated planning, prioritizing and tracking of progress towards development goals, andprovided regular updates to senior leadership team. Facilitated milestone reviews and technologyreadiness assessments by setting scope and expectations.• Developed requirements through collaboration with Marketing, Business Development, Operationsand QA/RA to identify user needs, business needs, manufacturing needs and regulatory standards.Resolved or optimized trade-offs between conflicting requirements. Influenced market research andclinical trial design to improve requirements definition and better inform engineering decisions.• Drove System architecture and technology selection through criteria based on customer or businessneeds and prioritized data collection efforts. Quantified architecture trade-off spaces and performedanalysis to facilitate down-selection. Partitioned system architecture into sub-systems and managedresulting interfaces through functional decomposition. Drove cross-functional and organizationalalignment and documented decisions with rationale.• Developed system models to analyze trade-off, guide design decisions, allocate requirements andtrack progress. Collaborated with Ops and Finance leaders to develop an extensive COGS model todelineate component costs, highlight planning gaps and steer development efforts.

San Diego, Ca

• R&D Core Team Lead for Mechanical Design and Process Development of the first fully-disposableContinuous Glucose Monitor (G6 Pro) intended for Type II diabetics and in partnership with Verily.• Collaborated with SMEs to develop a comprehensive strategy and schedule for ME design,development and V&V. Communicated necessary resources and timeline to Program Managers.• Tracked schedules and coordinated with cross-functional teams, partners and vendors fordevelopment, tooling, sterilization validations, clinical feasibility and pre-verification testing.• Provided technical leadership by applying lean six sigma methodologies, guiding interpretation ofdata, identifying design gaps and driving design improvements. Mentored younger engineers, andassisted in development, testing, debugging and documentation where resources were limited.• Designed and implemented pilot line for new sensor applicator through collaboration with R&D,Ops, QA and equipment vendors to design, develop and validate (IQ/OQ/PQ) new equipment,fixtures, processes and manufacturing instructions.• Planned and tracked development and de-risking activities leading up to design lock. Organizedrecurring meetings to track progress and updated core team.

San Diego, Ca

• Led rapid build/test cycles for design and process development of next generation product (G6).• Designed experiments, DOEs, test methods and test fixtures as the lead for characterization anddebug efforts. Communicated findings and collaborated with design team for improvements.• Planned and organized proof of concept, clinical and commercial feasibility activities, includingIngress Protection, 60601 safety, shelf-life, environmental stability & robustness testing.• Planned and coordinated daily pilot operations, prototype builds and sterilization validations.• Developed processes for manual and semi-auto assembly of complex mechanical systems.• Enabled clinical studies with validations, builds, safety assessments/testing and documentation.• Developed DV protocols and coordinated pre-verification test activities.

San Diego, Ca

• Designed and executed new assays to characterize electromechanical performance and mechanical integrity of advanced sensor and membrane designs. Improved control of variables, test capacity and in vivo correlations.• Developed, analyzed and validated new test media for greater in vitro to in vivo correlation.• Created VBA Scripts/Macros for automated data collection and analysis.• Debugged and mitigated commercial sensor quality concerns through successful root-cause failure analysis.• Delivered results in weekly meeting, maintained GDP lab notebook and published critical findings in lab reports.• Manufactured prototypes, developed MPIs, supported V&V testing activities and generated reports.

Berkeley, Ca

• Data analysis and field support for a growing tech start-up in the wine industry.• Created R Scrips to automate manual data extraction, processing, analysis and visualization.• Developed new algorithms for vine monitoring and deployed/debugged sensory hardware.