11/25/2020 - Currently overseeing the risk management remediation for approximately forty IVD devices to achieve EU IVDR and ISO 14971:2019 compliance.

• EU MDR Technical File remediation and submission for Class 2 Introducer Catheter• Risk Management leader and contributor (All facets of ISO 14971:2019/24971:2020• Transferred state-of-the-art hydrophilic coating technology to manufacturing.• Project Management responsibilities for EU MDR Remediation • Lead FDA Response action items for observations and continuous improvement.• Develop comprehensive guidance material for leveraging existing Test Method Validations to streamline new product development processes.• Participate in transferring quality batch management process to SAP S/4HANA ERP.• Quality Representative on projects resulting in successful 510(k) clearances.• Launch of legacy Class 3 medical device in Japan via PMDA• Assess and drive nonconformances for product complaints as they relate to design, process, and user FMEA’s• Remediate DHF and implement design changes of devices for ISO 80369-7• Test Method Validation SME for Terumo Medical Corporation R&D and manufacturing facility• EU MDR Risk Management File Remediation

As Project Team Lead, I led a team of five biomedical engineering students through the design control process of medical device development for a senior capstone project. The project was to design an innovative surgical retractor that met user requirements - specifically for the correction of Carpal Tunnel Disorder, the most common nerve compression disorder of the upper extremity. There are approximately 463,637 carpal tunnel releases done annually in the United States, and the user need for an innovative retractor was proposed to the team by clinicians at Delaware Orthopedic Specialists.

Worked on an engineering co-op assignment for 8 months in an FDA regulated, GMP, food grade, manufacturing facility and performed the following duties.• Assist in Product development projects for injection molded or extruded components or other products. Used AUTOCAD to design, validate, and implement improved components to in-house manufactured machinery. • Perform tasks while assisting other engineers for the purposes of evaluating new colorants, testing new products, evaluating processes and calibrating machinery.• Assist engineers in troubleshooting to optimize efficiency, safety, quality and downtime• Detailed documentation including process set up sheets and drawings• May include product development projects involving design of parts• Work as a team member with production, mechanics, Quality Assurance and machine shop personnel• Communicate with management on project plans and status• Must follow company procedures and policies

Worked with a team of two other fellow engineering students from Widener University on a contract job to modify current operations, and introduce novel manufacturing and quality control to a small cosmetic manufacturing company with the goal to increase profit margins, decrease downtime and waste, and improve overall efficiency.

- Delivering 5 STAR CUSTOMER SERVICE to every client- Safely operating non-CDL Junk Truck- Lifting and Removing Junk- Marketing

Cared for and provided mental and physical stimulation for rescue dogs originally from Animal Control of Philadelphia. Facilitated adoption processes and marketed in an effort to increase adoption rates.