Alex Mcdevitt Email & Phone Number

St. Louis, Mo, Us

St. Louis, Mo, Us

Montpellier, France, Fr

- Ensure compliance with quality policies, procedures, and practices.- Ensure solutions delivered meet end-user needs, safety/regulatory/quality requirements, and all other agreed-to business requirements.- Participate in the planning and execution of technical project work.- Facilitate and participate in the creation and maintenance of proper product documentation.- Ensure requirements are properly written and fully understood by various internal teams, including engineering, software development, quality assurance, operations, and regulatory.- Review and approval of technically complex documentation to ensure technical competence to relevant regulations and standards. - Knowledge of ISO 13485, ISO 14971, CFR 820.30, and EU MDR.- Development of R&D policies and best practices for Design Inputs, Design Constraints, and Design Outputs. - Create and maintain traceability among design input, design output, verification and validation, and risk management artifacts to ensure completeness and fully traceable design history file.- Support the preparation and presentation of information and status to leadership and other cross-department stakeholders.- Serve as a key member of a cross-functional project team consisting of electrical, software, mechanical, manufacturing, and quality engineers to achieve project deliverables.- Define and develop product and system architecture frameworks and architecture documents.- Work stakeholders to define and maintain system integration activities within projects.- Develop and document analytical models of system and subsystem behavior and interactions.

St Louis, Missouri, Us

- Understanding of ISO 14971 and IEC 62366 to lead projects as part of the Human Factors/Usability Engineering process - Understanding of ISO 13485 and its application across the QMS system- Scheduling of inter-department meetings for goal alignment on HF/UE process updates- Lead role in preparation, planning, and establishing of protocols for site visits, including inventory control, record keeping, and internal communications- Global resource for Training & Education initiatives and strategy. Aid in the development of key objectives, target audience, and content development

St Louis, Missouri, Us

System Testing:- Develop and conduct system end-to-end testing according to test documentation and quality assurance guidelines, including hardware, software, and firmware configurations- Medical disposable testing involving various sample sizes and material types- Experience with Helix Issue Management/ Test Case Management/ Requirements Management- Component and System testing on various electro-mechanical assembliesProduct Development/Project Management- Design of Test Fixtures for robotic systems using SolidWorks - Review, analysis, and updating of SOPS, work instructions, and Bill of Materials for current-gen magnet robotic systems and subsystems- Scheduling of testing cells/environments between multiple teams- Lead role in gap analysis of Human Factors/Usability Engineering process Training- Lead hands-on training of new hires for System Testing- Development of customer training strategy and supporting materials for newly fielded hardware and software systems- Consulted with QA to provide guidance for online training

Master Of Arts - Ma, Secondary Education And Teaching

Bachelors, History