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.

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.
• 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.
• 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.
• 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.

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.
• 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.
• 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.

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.