Open to opportunities

Muniza Ahmed

@munizaahmed

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Biomedical engineer experienced in medical device manufacturing, validation, R&D, and quality systems.

United States

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What I'm looking for

I’m seeking an engineering role within a patient-care environment where I can apply medical device manufacturing, validation, and quality systems to drive continuous improvement and support safe, high-quality outcomes.

I’m a Biomedical Engineer with hands-on experience supporting FDA-regulated medical device manufacturing in a cleanroom environment. At Applied Medical, I helped maintain optimal production yields by inspecting nonconforming devices, categorizing failure modes, and performing scrap and defect trend analysis.

I strengthen quality systems through root-cause investigations and deviation support. I supported SCARs with stakeholders, executed equipment validation activities including IQ and PQ, and authored validation documentation, pFMEA, and supporting reports within the Quality Management System (QMS).

My background also blends engineering design with rigorous testing and usability work. At Toro Neurovascular, I created neurovascular models using SolidWorks, 3D printing, and silicon molding, programmed a Mark-10 Force Tester for catheter tip buckling testing, gathered testing data, and performed statistical analysis to verify catheter designs.

Across early-stage R&D and capstone work, I focus on practical improvements that hold up to clinical and regulatory expectations. I led CAD design and fabrication of neonatal medical device prototypes and designed ISO 11607 packaging, and in my Alcon collaboration I developed a semi-automated manufacturing process improvement that reduced manual soldering time.

Experience

Work history, roles, and key accomplishments

Group Process Development Engineer

Applied Medical

Jul 2024 - Jul 2025 (1 year)

Supported manufacturing operations for a surgical device line in a cleanroom environment to maintain production yields. Performed scrap/defect trend analysis, executed equipment IQ/PQ validation, authored validation documentation and pFMEA, and supported SCAR root-cause investigations and process deviation responses.

Medical Device Manufacturing PFMEA Root Cause Analysis SCAR Scrap And Defect Trend Analysis GMP Cross Functional Collaboration

Research & Development Engineer

Toro Neurovascular

Nov 2023 - Jun 2024 (7 months)

Built neurovascular models using SolidWorks, 3D printing, and silicon molding to support simulated use testing for catheter navigation and clot retrieval. Programmed a Mark-10 force tester and developed a catheter tip buckling test method aligned to ISO 10555-1:2023, performed statistical analysis, and executed QCBD software validation with physician collaboration for usability testing.

Solidworks 3D Printing Biomechanical Test Method Development Mark 10 Force Tester ISO 10555 1:2023 Statistical Analysis Usability Testing QCBD Software Validation Catheter Testing

R&D Engineer

Microbiomechanics Lab (NeoCare Innovations)

Mar 2022 - Oct 2023 (1 year 7 months)

Supported early-stage R&D through iterative prototyping, testing, and design refinement for neonatal medical devices. Led CAD design and fabrication of device prototypes and designed medical device packaging for hospital use in compliance with ISO 11607 requirements.

Prototyping CAD Design 3D Printing Medical Device Prototype Fabrication Technical Documentation

Engineering Intern

Applied Medical

Jun 2023 - Sep 2023 (3 months)

Designed a prototype fixture to enable functional testing of a surgical device during production. Drafted validation strategies, time studies, and quality reports to support manufacturing improvements, and investigated root causes of customer returns by analyzing nonfunctional devices.

Prototypes Functional Testing Validation Strategy Writing Time Studies Quality Reporting Root Cause Analysis