Joe M. Email & Phone Number

• Perform root cause investigations of complaints, conduct risk assessment to determine severity and probability of events, document adverse events, and perform root cause analysis during limited product launch• Collaborate with Quality Assurance (QA) to ensure timely review and closure of Corrective And Preventative Actions (CAPA), Non-Conformance Reports (NCR), and Supplier Corrective Action Reports (SCAR)• Coordinate with Software, Regulatory Assurance (RA), QA, Systems, Hardware Engineering teams to update system-level requirements and document the change analysis, design, and verification results• Maintain the traceability matrix to ensure Continuous Renal Replacement Therapy (CRRT) device is designed and tested to internal, federal, and international standards• Develop test protocols, conduct testing, and author test reports for verification and validation of system-level requirements• Evaluate requirement modules to ensure risk, control measures, and product requirements are satisfied and linked appropriately

Brooklyn Park, Mn

Developed test protocols and methods to complete design verification, design validation, and process validation prior to medical device submission to the FDA. Worked closely with Quality Assurance to ensure timely review, implementation, and closures of CAPAs, non-conformances, supplier corrective actions, and deviations. Effectively corresponded with customers and coworkers to manage multiple builds and testing of product.

Authored Software Validation Plans/Protocols, Software Validation Tests, and Software Validation Reviews for syringe and ambulatory infusion pumps. Software Test Lead for continuation projects on infusion pumps, led of test engineers/technicians during dry run and formal test execution, reviewed tests for quality and reliability, performed formal results review, and worked hand-in-hand with Design/Quality Assurance to ensure timely review and release of project documentation.

Greater Minneapolis-St. Paul Area

The Remediation Engineer position required evaluating field reports, product returns, and product analysis results for Neuromodulation products to determine medical device reporting eligibility. Responsible for maintaining awareness of new products, government regulations, and requirements, while providing audit support as needed. Become familiar of the following regulations: 21 CFR, Section 820, Quality System Regulation and 21 CFR, Section 803, Medical Device Reporting.

Maintain the University's Golf course by operating heavy machinery including mowers, tractors, and skidloaders. Responsible for getting up early (5:00 am start) and efficiently preparing the course before golfers arrive. The job also required ability to follow directions and organize teams for landscaping projects.