Erika Debnam Email & Phone Number

Morrisville, North Carolina, United States

• Responsibilities:
• Authorship of risk management deliverables for medical devices, combination products, and software as medical devices (SaMD) in accordance with ISO 14971
• Project-level management of design controls for SaMD in accordance with ISO 13485 and IEC 62304
• Oversight of medical device (including IVD) and combination product (device constituent) complaint investigations and complaint backlog elimination in accordance with 21 CFR 820
• Provision of technical expertise… Show more Responsibilities:
• Provision of technical expertise and leadership in device and use-related root cause analyses

Morrisville, North Carolina, United States

• Kymanox Academy Rotational ProgramResponsibilities:
• Complaint investigations and complaint backlog elimination for medical devices and combination products
• Drafting of design history file (DHF) documentation, including risk management file (RMF) deliverables
• Drafting of standard operating procedures (SOPs)
• Drafting of Human Factors (HF) planning deliverables

Durham, North Carolina, United States

• Advanced Interconnect Technology DivisionLab techniques in a semiconductor cleanroom environment:
• Identification of incoming wafer components and defects
• Operation of descum and spray solvent tools
• Device coating, including automated coater tools and hand pouring
• Pouring and use of developer baths
• Measurement of vias to confirm proper specifications

Raleigh, North Carolina, United States

• Responsibilitites:
• Aid two first-year Goodnight Scholars in the first six weeks of their college transition, including but not limited to personal support and connections with on-campus resources

Durham, North Carolina, United States

• Corporate Computer-Aided EngineeringResponsibilities:
• Development of material testing simulations using finite element analysis (FEA) technique (Abaqus/Standard and Abaqus/Explicit)
• Performance of FEA mesh refinement studies to ensure convergence of computed solution
• Development of CAD model test fixture designs (SolidWorks) for in-lab material tests
• Material testing using 3D printed test fixture prototypes (Instron testing machine)

Greensboro, North Carolina, United States

• Young Scholars Program and NSF Engineering Research Center for Revolutionizing Biomaterials research grantResponsibilities:
• CAD model and finite element analysis (FEA) simulation redesign (SolidWorks and Abaqus/Standard) in alignment with ASTM standards for axial pull-out testing
• Preliminary axial pull-out testing (Instron testing machine)

Greensboro, North Carolina, United States

• Young Scholars Program and NSF Engineering Research Center for Revolutionizing Biomaterials research grantResponsibilities:
• Review of ASTM standards for axial pull-out testing
• Development of axial pull-out testing protocol compatible with Bluehill 3 software (for use on Instron testing machine)