Minneapolis, Minnesota, United States
I am an accomplished Systems Engineer with extensive experience driving medical device R&D initiatives, integrating subsystems, and ensuring compliance for regulated Class II/III devices. With a strong foundation in requirements management, verification and validation (V&V), and risk analysis, I specialize in translating complex clinical and technical needs into robust, compliant solutions that advance patient safety and innovation. My value lies in bridging the gap between technical skills and regulatory precision. I’ve led cross-functional teams through the design, integration, and optimization of critical subsystems, consistently delivering solutions that meet FDA, ISO, and IEC standards while improving efficiency, accelerating regulatory submissions, and supporting patient-focused outcomes. Key career highlights include: Proposed and implemented optimized data analysis workflows at Mozarc Medical, cutting team size from three to one while improving turnaround time and operational efficiency. Submitted a patent currently under USPTO review, showcasing innovation in consumable system integration for dialysis platforms. Reduced review cycles by developing validated Minitab analyses for regulatory submissions, enabling same-day outputs and accelerating FDA approval readiness. Completed blood tubing subsystem testing ahead of schedule, delivering early FDA submission reports and confirming compliance with safety requirements. Designed and built test benches at Medtronic, resolving recurring system errors through root cause analysis and corrective actions that improved reliability across renal care platforms. Throughout my career, I’ve been passionate about optimizing processes, standardizing engineering practices, and applying advanced tools—such as Minitab, LabVIEW, and AI-driven workflows—to reduce risk, accelerate development, and deliver reliable devices. From authoring technical documentation and conducting FMEAs to collaborating with global teams, I ensure every system and process I touch meets the highest standards of safety, quality, and performance. Core Competencies: Characterization Testing | Design Control & Review | Data Analysis | DFMEA | Process Improvement | Risk Assessment | Test Methods | Root Cause Analysis | Test Bench Development | Patent Submission | Regulatory Compliance | Troubleshooting | Technical Documentation | Medical Device ISO Standards | FDA Requirements | NSF Standards | EPA Requirements | Workflow Optimization | JIRA | Jama | LIMS | QMS | PLM | TMV | TMD | HACCP | GMP | GDP | GLP
• Direct cross-functional integration of a new consumable system into existing dialysis platforms, defining and implementing design inputs and outputs while ensuring traceability and compliance with critical pathway requirements. • Proposed and implemented optimized data analysis workflows, reducing team size from three to one while significantly improving turnaround time and resource efficiency. • Drive data analysis using Minitab on a sensor re-design in our Hemodialysis system working in a cross function global team. Data analysis used to influence integration and characterization testing to ensure robust design and decision. • Submitted a patent currently under USPTO review, advancing proprietary innovation and strengthening IP portfolio. • Presented at internal Science and Technology conference showcasing patent work and the use of AI tools for data analysis and code generation. • Requested by a different team to support because of work ethic and willingness to learn/adapt during critical timeline. • Co-Chair of employee engagement group called Cheerco. Planning events and activities to increase employee morale, engagement, and networking. Chair of Life Stages employee resource community, working closely with HR, Leadership, and other employee resource groups to support employee engagement and initiatives.
• Expanded role to assist in GLP lab study with blood for FDA IDE submission. Use of Minitab for data analysis to be included in IDE submission to show sub-system safety and meeting requirements. • Developed multiple validated and verified Minitab analysis files to assess compliance with system requirements, streamlining data review for regulatory submissions. • Partnered with systems engineering to identify additional testing needs and refine data sets for inclusion/exclusion in regulatory packages. • Designed sub system components to meet ISO, NSF, FDA, and EPA requirements; authored specifications and design requirement documents. • Directed continuation of System and Component level FMEA, coordinating with component owners to ensure risk assessments were complete and compliant. • Managed all chemistry related JIRA issues across multiple sites, ensuring timely resolution and traceability.
● Executed system and component level testing using data acquisition systems, LabVIEW, and statistical analysis tools to verify, test, and characterize performance ● Developed and optimized test methods for materials and functional sub components; authored reports and documentation in compliance with design controls. ● Conducted root cause analyses on test system incidents, presenting findings and corrective actions to technical leadership. Leading in a change in the system to remove sensor. ● Designed, built, and maintained test benches for integration and feasibility activities, coordinating with international teams for deployment. ● Applied statistical analysis (Minitab, Excel) to evaluate system performance and support design decisions. ● Ensured compliance with FDA regulations and internal quality systems throughout all development and testing activities.