Allison R•••

About

On the record

As the Systems Engineering Manager at Lima, I have the following skills and responsibilities: • Leading requirements management activities, which includes performing voice of the customer (VOC) studies in conjunction with marketing and other stakeholders, identifying requirements and specifications for mechanical, software, and electrical systems, and developing and maintaining documentation around requirements and specifications. • Leading risk management activities, which includes identifying potential hazards, assessing hazardous situations and scenarios, and creating and maintaining risk file documentation. • Performing advanced risk analysis using FTA, ETA, or other advanced methods. • Assisting test engineers with review and execution of test plans, test cases, and test case execution records to assure coverage during the verification and validation (V&V) process. • Maintaining traceability between requirements, specifications, hazards, and V&V activities and outcomes. • Leading activities around usability studies and Human Factors Validation (HFV) planning, execution, and analysis. • Working with quality assurance specialists to create templates and maintain relevant systems documentation in the Design History File (DHF). • Directly supporting regulatory submissions to the FDA and notified bodies. • Acting as a subject matter expert in design control standards and implementation within the company and providing advice to senior management on areas of expertise. • Responsible for defining and documenting Systems Engineering processes and practices for incorporation into the company Quality Management System (QMS). • Expertise with relevant industry standards for medical devices, including ISO 13485, ISO 14971, IEC 62304, IEC 60601-1 series, IEC 62366-1, 21 CFR, and the MDR. • Active member of INCOSE; passed Certified Systems Engineering Professional (CSEP) Exam in July 2023