# Dennis Cody > Engineering Director (Software, Systems, Data Analytics, PMO) Location: El Cerrito, California, United States Profile: https://flows.cv/denniscody An empowering visionary Director of Engineering who sets goals for delivering safe and effective medical solutions to customers while meeting business needs. Directs, mentors, and inspires team leads and members to collaborate and own their contributions, tailoring guidance based on individual skills and needs. Demonstrated leadership in medical device development, launch, and post-market support and updates. Additional capabilities deployed to this objective are: Specialties: My specialties are Systems Engineering, Leadership, Project Management, Software Development, Data Analytics, System Integration, Test Engineering, Collaboration, Workflow and Instrument Automation, Regulatory Strategy, Process, Requirements Management, and Agile Development. ## Work Experience ### Founder @ STRIDE Med Dev Systems Jan 2025 – Present | SF Bay Area, California I have a passion for creating impactful medical devices that improve lives. With a focus on Systems Engineering and strategic planning, STRIDE leads teams to deliver innovative solutions that meet customer needs and business goals. My expertise in Systems Engineering, V&V, software development and data analytics will help you drive successful product launches and post-market support activities. ### Director Of Engineering @ Cytovale Jan 2022 – Jan 2025 | San Francisco Bay Area Director, Engineering Cytovale System for aid in diagnosing sepsis PMO, Software, Systems Engineering and Data Analytics (~20 direct & indirect reports) Started as a Sr. Manager of Design Verification, promoted to Director in 2022 - Train and mentor teams of Software, Electrical, Biomedical and Systems Engineers. - Build Project Management Team, drive and guide communication template for project teams, executive leadership, and the company. - Develop project schedule, resource and budget estimates for development team. - Manage the cross-functional team (including Quality and Regulatory) implementation of post-release change management process following Current Good Manufacturing Process (CGMP). - Drive process improvements to optimize performance, including sponsoring and guiding implementation of Requirements and Test Tool, and guiding implementation of QMS (Quality System) and PLM tool following ISO 13485 and 14971. - Lead team through prioritization and implementation of hardware and software improvements. - Reporting to COO, lead effort with cross functional leaders analyzing data to implement most impactful improvements for customers and business using the Pareto principle and impact effort matrices. - Champion clear risk-based improvements to design and process. ### Senior Manager - Design Verification @ Cytovale Jan 2021 – Jan 2022 | San Francisco, California, United States Cytovale is developing a fast test (< 10 minutes) for the detection of sepsis, and I led the Design Verification effort in preparation for the submission for 510(k) clearance. ### Senior Staff Systems Engineer @ Grifols Jan 2013 – Jan 2021 | Emeryville, CA Started in 2013 as a Sr. Systems Engineer, promoted to Staff in 2017, Sr. Staff in 2019. Develop and support automated in-vitro diagnostics (IVD) systems and software. As a leading member of cross-functional project teams, work as a subject matter expert evaluating, architecting, developing and commercializing IVD systems by utilizing expertise in systems engineering. - Lead Systems Engineer (3 marketing reps and 5 systems engineers) for program consisting of projects for a new automation system, new middleware, and an updated IVD instrument. - Train and mentor Systems Engineer (direct report) and test engineers. - Responsible for system concept, workflows, sequence diagrams, use cases, and system requirements for new platform. - Develop requirements and risk management documents complying with FDA, ISO standards. - Develop Impact Analyses for system updates and guide test strategy. - Work closely with marketing to understand customer needs, obtain voice of customer input, review and develop into customer requirements. - Manage collaboration with vendors and business partners regarding requirements, developing use cases, making implementation decisions, evaluating prototypes and developing tests. - Improve Standard Operating Procedures with Test and Quality groups, improving processes. - Lead requirements management training classes and help define training material. ### Test Engineer, Staff @ Siemens Healthcare Jan 2011 – Jan 2013 | Berkeley, California Responsible for leading the testing activities, including planning, design, writing, and execution, related to Molecular Diagnostics TRUGENE, and VERSANT kPCR. ### System Engineer @ Siemens Healthcare Jan 2006 – Jan 2011 | Concord, CA * Acted as HW Project lead for the last two phases of the project that included features for unflat energies and a new imaging with less dose. Tasks include leading main reviews for project milestones, coordinating activities leading to the main reviews, updating project management plan, trace matrix, creating impact analyses. * Define requirements and scope, define quality measures and tests. * Responsible for design concepts, requirement specifications, defect management, integration of hardware and software components underlying a radiation therapy linear accelerator system for cancer patients. * Establish traceability between system functional specifications and its source requirements. * Develop project specific requirements management plans and prepare the requirements management environment * Develop system architecture in collaboration with the SW architecture team. * Support the realization process to ensure proper requirements implementation. * Plan and coordinate system integration with Project Management and Technology. * Analyze project ideas and proposals for feasibility and impact on existing commitments. * Development contact supporting and troubleshooting hardware Service and Installation issues. ### Lead - Integration Test @ Siemens Healthcare Jan 2005 – Jan 2006 Led team of 3-5 testers developing testplans and procedures, defining traceability, executing procedures and creating reports. ### Senior Quality Assurance Engineer @ Parametric Technology Corporation Jan 1995 – Jan 2000 Created Test Plans, Procedures, and automated scripts for 7 major and 3 minor releases of the 3D CAD software Pro/Engineer and 3D CAE software Pro/Mechanica. ## Education ### M.S. in Biomechanical Engineering Stanford University ### B.S. in Mechanical Engineering Worcester Polytechnic Institute ## Contact & Social - LinkedIn: https://linkedin.com/in/denniscody - Portfolio: http://alum.wpi.edu/~dcody/ - Portfolio: http://www.medical.siemens.com/webapp/wcs/stores/servlet/ProductDisplay?storeId=10001&langId=-11&catalogId=-11&catTree=100010,1008643,12757,1012165,1014065&productId=180106 - Portfolio: https://cytovale.com/ --- Source: https://flows.cv/denniscody JSON Resume: https://flows.cv/denniscody/resume.json Last updated: 2026-04-13