Summary
Overview
Work History
Education
Skills
Languages
Timeline
Generic

Basma Hassan

Aldie

Summary

Strategic Engineering Leader with excellent track record of successfully navigating teams through technical challenges to deliver quality medical devices into the marketplace. Experienced in collaborating and influencing to innovate solutions that result in positive outcomes for patients, medical professionals, and corporate stakeholders. Experienced in hands on medical device development through all stages of design control, project management including design input development, design output documentation, verification and validation, regulatory submission, and post-market surveillance.

Overview

17
17
years of professional experience

Work History

Sr. Quality Improvement Engineer

Stryker Corporation
03.2022 - Current
  • Manage projects and lead cross-functional quality improvement initiatives across operations, suppliers, and shared services to address critical product and process performance issues.
  • Manage CAPA and non-conformance (NC) projects, ensuring timely root cause analysis, corrective implementation, and regulatory compliance.
  • Serve as SME during internal and external audits conducted by regulatory agencies, notified bodies, and competent authorities.
  • Apply statistical methods for process control and quality performance monitoring; developed KPIs, analyzed trends, and drove continuous improvement actions.
  • Own the creation, revision, and approval of quality documentation including SOPs, and quality records.
  • Supported product field actions, complaint analysis, and commercial hold activities to mitigate risk and ensure product integrity.
  • Partner with manufacturing engineering to improve inspection methods, sampling plans, and legacy product quality.
  • Lead quality system projects of a moderate scope and complexity.
  • Supports manufacturing transfers to/from other plants/facilities, executing appropriate quality activities.
  • Collaborate with Regulatory to execute the creation and revisions of Instructions for Use (IFUs).
  • Dispositions non-conforming product within the material review board (MRB), issuing NCs as appropriate.
  • Maintain KPIs for monitoring process and/or product quality, perform analysis, and interpret trends, identifying and activating appropriate actions as necessary.

Sr. Quality Improvement Engineer

Euclid Systems Corporation
11.2021 - 03.2022
  • Proactively investigate, identify, and implement best-in-class Quality Engineering practices.
  • Responsible for timely and effective coordination and/or execution of assigned development project activities.
  • Establish and propose effective corrective / preventive action plans.
  • Lead in implementation of quality assurance plans, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
  • Effective leader in supporting quality disciplines, decisions, and practices.
  • Review and approve product and process qualification and validation and other change control related documents.
  • Develop product/process assurance plans.
  • Identify and implement effective process control system to support the development qualification products.
  • Ensure QA, FDA, and ISO compliance in all areas of responsibility.
  • Identify non-conformance trends and develop technical investigation plans.
  • Investigate, analyze customer internal complaints, track quality trends and initiate action items to resolve issues.
  • Develop and implement strategic quality plans, master validation plans, validate protocols, inspect plans and quality/regulatory compliance operating procedures to meet FDA and ISO requirements.
  • Manage assigned corrective preventive and improvement actions.
  • Provide training and support for quality system, processes, and quality engineering practice.

Senior Technical Consultant – Medical Device Test Engineer

United States Army Medical Research and Development Command (USAMRDC)
02.2021 - 11.2021
  • Led Engineer for prototype and commercialized medical devices for the US Army. Liaison between USAMRDC and external customers. Resolved issues by listening to the team, making quality decisions, and clearly communicating recommendations.
  • Collaborated with a cross-functional team to develop test protocols, test equipment, and test methods.
  • Performed developmental and environmental testing of medical devices and support equipment.
  • Performed engineering expertise regarding test design, set-up, and execution in accordance with the most current version of MIL-STD.
  • Established Test Plans and Test Summaries.
  • Applied knowledge of problem-solving skills using “fishbone “diagram to identify possible causes of a problem and its’s effect.
  • Provided input into risk management processes.
  • Completed data analysis of process and compared testing results between different medical devices.
  • Led the development of different auto injector prototypes, improved quality processes.
  • Identified possible root cause of auto injector failure, implemented a solution to fix it, and successfully established a new design to improve the quality of the auto injector.
  • Collaborated with Integrated Product Team (IPT)/Working Group meetings to enhance processes and drive efficiency.
  • Identified recommendations for USAMRDC Test Branch equipment upgrades.
  • Effectively drove professional experience in military medical operations.
  • Establish professional experience in developing test criteria for military medical devices.
  • Led recommendations for test requirements to various customers of the MRDC Test Branch.
  • Coordinated with USAMRDC, other DoD activities, the manufacturer, the requesting official, and other interested parties regarding the testing of assigned systems.
  • Prepared and updated management documentation for programmatic briefings and reviews.
  • Reviewed and updated the USAMRDC Test Branch Standard Operating Procedures (SOPs) to ensure they are current and align with policy changes and improvements.
  • Developed an understanding of the functioning and intended use of the medical devices being tested as well as the Army and DoD field medical force structure.

Biomedical Engineer Patent Examiner

United States Patent and Trademark Office
08.2020 - 02.2021
  • Reviewed the validity of patent applications for medical and surgical devices.
  • Reviewed Patent applications to determine compliance with federal Law regulations and scientific principles, including technical information, electrical schematic drawings, 3-D mechanical drawings.
  • Reviewed and evaluated the validity of patent applications for medical and surgical devices.
  • Prepared legal documents based on technical information and references of medical devices.
  • Utilized Patent database to assess novelty and innovation by searching patents for similar products.
  • Communicated with lawyers to negotiate solutions for improving patent applications.

Program Manager – Biomedical Engineering and Life Sciences Education

SACM Cultural Mission
01.2013 - 08.2020
  • Managed all aspects of program development and fostered business partnerships with 150 universities, advising 500+ international biomedical engineering students to address academic and cultural adjustment challenges.
  • Facilitated communications with participants and integrated program improvement recommendations.
  • Evaluated internship and volunteer opportunities and developed detailed reports outlining program success.
  • Reconciled $27M annually in student funds; maintained financial records and tracked budget plans.
  • Contributed to conceptualizing, developing, and finalizing professional development/training materials.
  • Served as company liaison to represent the Cultural Mission within the scientific community and conferences.
  • Provided mentoring and leadership to junior engineers and other key stakeholders to develop solutions that meet international educational guidelines to provide good learning experience for students.

Clinical Biomedical Engineering

Alseif Hospital
06.2008 - 12.2012
  • Developed and maintained an efficient Engineering Maintenance Department, ensuring suitable response times. Resolved customer complaints and quality issues through CRM software
  • Managed direct maintenance labor resources and contractors and alteration / upgrade projects.
  • Provided translation and interpretation services for international clinical trials teams.
  • Coordinated and attended team activities to ensure timely documentation of actionable results.
  • Communicated regularly with department heads, nurses, and fire / health / safety officers.
  • Conducted research to solve problems in Medical Procurement.

Education

Master of Science - Biomedical Engineering

JOHN HOPKINS UNIVERSITY
Baltimore, MD
12.2020

Bachelor of Science - Biomedical Engineering, Minor in Mathematics

VIRGINIA COMMONWEALTH UNIVERSITY
Richmond, MD
05.2008

Skills

  • ISO 14971 and ISO 13485
  • Six Sigma – Green Belt
  • Design Control, FMEA, Validation
  • FDA Regulations, 21 CFR Part 820 standards
  • Department of Defense (DoD) requirements
  • Test and Evaluation (T&E) requirements
  • Matlab, LabView, AutoCAD, ImageJ, Solid Works Basics

Languages

Arabic
Native or Bilingual

Timeline

Sr. Quality Improvement Engineer

Stryker Corporation
03.2022 - Current

Sr. Quality Improvement Engineer

Euclid Systems Corporation
11.2021 - 03.2022

Senior Technical Consultant – Medical Device Test Engineer

United States Army Medical Research and Development Command (USAMRDC)
02.2021 - 11.2021

Biomedical Engineer Patent Examiner

United States Patent and Trademark Office
08.2020 - 02.2021

Program Manager – Biomedical Engineering and Life Sciences Education

SACM Cultural Mission
01.2013 - 08.2020

Clinical Biomedical Engineering

Alseif Hospital
06.2008 - 12.2012

Bachelor of Science - Biomedical Engineering, Minor in Mathematics

VIRGINIA COMMONWEALTH UNIVERSITY

Master of Science - Biomedical Engineering

JOHN HOPKINS UNIVERSITY

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Basma Hassan