Erika Debnam Email & Phone Number

Durham, Nc, Us

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:• 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 and leadership in device and use-related root cause analyses• Support quality system gap analyses for SaMD Show less

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• Assistance with solder bump plating techniques• Bump shear and bump height measurements• Final device… Show more 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• Assistance with solder bump plating techniques• Bump shear and bump height measurements• Final device inspections to ensure quality interconnects Show less

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)