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, 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.

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.

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.

Responsible for leading the testing activities, including planning, design, writing, and execution, related to Molecular Diagnostics TRUGENE, and VERSANT kPCR.