Basma Hassan
Aldie, VA 20105-5693,VA
Summary
Project Manager and Senior Quality Engineer with extensive experience in medical devices, specializing in cross-functional projects of medium to high complexity. Demonstrated success in customer implementations and supplier quality initiatives compliant with ISO 13485 and FDA 21 CFR 820. Skilled in developing project strategies, coaching teams, and advising stakeholders effectively. Credentials include PMP training, Six Sigma Green Belt, and ISO 13485 certification.
Overview
17
17
years of professional experience
1
1
Certification
Work History
Senior Project Engineer
VB Spine formerly Stryker
Leesburg, VA
03.2022 - Current
- Led cross-functional site readiness and supplier quality projects for medium to high-risk implementations.
- Collaborated with architects, engineers, contractors, and suppliers to ensure compliance with construction and electrical specifications.
- Facilitated stakeholder meetings throughout project phases to align teams on schedules and deliverables.
- Developed pre-installation workflows and compliance documentation, reducing delays and enhancing efficiency.
- Mentored teams on CAPA and root cause analysis, ensuring adherence to ISO 13485 and FDA standards.
- Optimized documentation practices in MasterControl and TrackWise, increasing visibility into project milestones.
- Coordinated supplier audits to verify compliance and drive continuous improvement in installation quality.
- Led initiatives that resulted in decreased complaints from suppliers through quality improvements. Coordinated supplier audits to uphold regulatory standards while fostering continuous improvement.
Senior Project Engineer
Euclid Systems Corporation
Sterling , VA
11.2021 - 03.2022
- Directed project activities across engineering, operations, and quality to meet established milestones.
- Managed development projects utilizing CAPA and process control systems to enhance product quality and compliance.
- Executed quality improvement initiatives that streamlined operations and achieved measurable cost savings.
- Partnered with vendors and suppliers to lead contract reviews, qualifications, and compliance audits.
Delivered project updates to senior leadership on compliance, validation, and corrective action initiatives.
Senior Technical Consultant – Project Engineer
United States Army Medical Research & Development
Frederick, Maryland
02.2021 - 11.2021
- Managed engineering test projects for prototype and commercial medical devices, directing over $1M in initiatives.
- Collaborated with multi-disciplinary teams to achieve project milestones within strict timelines.
- Facilitated communication between USAMRDC and external contractors to fulfill requirements and minimize risks.
- Enhanced supplier inspection processes by qualifying contractors and reducing inspection frequency.
- Supervised validation and verification activities, utilizing statistical techniques to ensure regulatory compliance.
- Conducted workshops to improve team understanding of technical processes and tools.
- Supported project management by coordinating resources across multiple departments.
- Reported project status updates to project manager twice weekly regarding open projects.
BIOMEDICAL ENGINEER PATENT EXAMINER
United States Patent and Trademark Office
Alexandria, Virginia
08.2020 - 02.2021
- Evaluated patent applications for medical and surgical devices, ensuring compliance with federal regulations.
- Assessed technical information, including electrical schematics and 3-D mechanical drawings, to establish patent validity.
- Utilized patent databases to identify novelty and innovation among similar products.
- Prepared legal documents with references and technical data for medical devices.
- Collaborated with attorneys to negotiate enhancements within patent applications.
- Reviewed patents for adherence to scientific principles and regulatory standards.
- Conducted comprehensive reviews of applications to verify technical accuracy and relevance.
Program Manager
SACM Cultural Mission
Fairfax, Virginia
01.2013 - 08.2020
- Managed comprehensive program development and established partnerships with 150 universities.
- Advised over 500 international biomedical engineering students on academic and cultural adjustments.
- Facilitated communications with participants, and implemented recommendations for program improvements.
- Evaluated internship and volunteer opportunities, producing detailed reports on program outcomes.
- Reconciled $27 million in annual student funds while maintaining financial records and tracking budgets.
- Contributed to the creation and finalization of professional development and training materials.
- Acted as a liaison to represent the Cultural Mission at scientific conferences and within the community.
- Provided mentorship and leadership to junior engineers, ensuring compliance with international educational standards.
CLINICAL BIOMEDICAL ENGINEERING
Alseif Hospital
Kuwait , Kuwait
06.2008 - 12.2012
- Established an efficient Engineering Maintenance Department, achieving optimal response times.
- Resolved customer complaints and quality issues using CRM software.
- Managed direct maintenance labor resources and contractors for upgrade projects.
- Provided translation and interpretation services for international clinical trial teams.
- Coordinated team activities to ensure prompt documentation of actionable results.
- Maintained regular communication with department heads, nurses, and safety officers.
- Conducted research to address challenges in medical procurement.
- Contributed innovative ideas and solutions to enhance team performance and outcomes.
- Prioritized and organized tasks to efficiently accomplish service goals.
Education
Master of Science - Biomedical Engineering
Johns Hopkins University
Baltimore, MD12-2020
Bachelor of Science - Biomedical Engineering
Virginia Commonwealth University
Richmond, VA05-2008
Skills
- Supplier quality assurance
- Regulatory compliance
- Project management
- Continuous improvement
- Quality management
- Root cause analysis
- Supplier evaluation
- Team leadership
- Six Sigma methodologies
- Measurement system analysis
- Cross-functional collaboration
- PPAP submissions
- Relationship management
- Problem solving
- Attention to detail
- Effective communication
Certification
- Lean Six Sigma Green Belt
- QMS Training for Medical
Devices: FDA and ISO 13485 - PMP
Languages
English
Native/ Bilingual
Arabic
Native/ Bilingual
References
References available upon request.
Timeline
Senior Project Engineer
VB Spine formerly Stryker
03.2022 - Current
Senior Project Engineer
Euclid Systems Corporation
11.2021 - 03.2022
Senior Technical Consultant – Project Engineer
United States Army Medical Research & Development
02.2021 - 11.2021
BIOMEDICAL ENGINEER PATENT EXAMINER
United States Patent and Trademark Office
08.2020 - 02.2021
Program Manager
SACM Cultural Mission
01.2013 - 08.2020
CLINICAL BIOMEDICAL ENGINEERING
Alseif Hospital
06.2008 - 12.2012
Master of Science - Biomedical Engineering
Johns Hopkins University
Bachelor of Science - Biomedical Engineering
Virginia Commonwealth University