Elisabeth Menning Email & Phone Number

Indiana, United States

Volunteer Indiana State Coordinator

Merrillville, In

Role Progression: • Lead Regulatory Studies Analyst (8/2014-8/2021), • Senior Regulatory Analyst (12/2012-8/2014), • Economic Development Support Analyst (6/2010-12/2012), • Temp (3/2009-6/2010)Key contributor to success of department and of company. Provided cornerstone support for regulatory filings and business systems analysis studies.• Consistently ensured state and federal regulatory compliance; demonstrated accountability• Managed and led multi-disciplinary project teams with superlative organization and communication skills; planned and facilitated effective meetings• Interfaced well with people at all levels of the organization and with both technical and business personnel; ability to convey technical knowledge to non-technical audiences• Utilized expert skills in MS Excel, project management, data science, data-driven visual presentations, continuous improvement, and technical writing and editing• Proactively identified opportunities for improvement, formed solutions to business problems, and made recommendations for needed software, tools, and processes• Coordinated with other regulatory personnel to develop strategies to meet current and long-term organizational goals and guide corporate decision making• Functioned as liaison between business operations and information technology teams, and as point of contact for division’s programming requests• Gathered business requirements, performed work both independently and in collaboration with IT personnel to scrub datasets and develop optimum queries and reporting mechanisms for variety of needsSpecialties:• Data Analysis/Data Science • Regulatory Compliance • Project Management • Business Systems Analysis • Continuous Improvement • Written and Verbal Communications • Team Leadership • MS Excel / Access / SQL • Complex Regulatory Rate Case Studies • Policy and Process Review • Technical Documentation • Employee Resource Group Leadership

Other Professional Experience prior to Feb 2009Maintenance Engineering Analyst (ArcelorMittal; steel mill; temp work) ● Reliability Maintenance “jack-of-all-trades” engineering and administrative workComputer Application Development Analyst / Computer Programmer / Database Developer (several companies; 8 years) ● User-specific C++ application programming, software validation, technical writing, business / technology liaison work, robust Excel models, Access databases, other programming Business Owner / Nonprofit President (self-owned businesses; 20+ years concurrent with other work) ● Business operations, office management, community partnership building, volunteer and intern training and supervision, customer and vendor relations, technical writing and editing, event planning, government filings Senior Control & Propulsion Instructor and Engineer (NASA-JSC; federal space program; 12 years) ● Trained astronauts and flight controllers in the operations and malfunction procedures of the space shuttle control and propulsion systems, long-range planning, senior leadership presentations, flight controller certificationPrimary skills developed or utilized during this period: • KPI development & tracking• Volunteer management • Marketing - customer outreach• Building business partnerships• Support group programming & facilitation • Event planning (1000-attendee regional festival, local & regional seminars)• Staff & employee training & development • Team leadership• Computer programming (C++, Unix)• Manufacturing process optimization analysis• Medical device testing and regulatory compliance• Procedure documentation • Technical writing & editing• Software implementation • Technical instruction• IT consulting• Quality assurance • Customer relationship management• Long range planning• Engineering analysis

Merrillville, Indiana, United States

Medical manufacturing company. Assisted company president in variety of projects, including regulatory affairs, product testing, quality assurance, engineering, materials management, and information technology work.● Designed product testing protocol in alignment with FDA regulations; conducted testing and documented procedures and results● Prepared and submitted successful 510(k)s for a variety of silicone medical devices● Conducted quality review and validation of packaging, labeling, and technical specifications, and documented and streamlined materials management processes● As information technology point of contact, maintained server, upgraded computer applications, and implemented new software system company-wideSpecialties:● Regulatory Compliance ● 510(k) Submissions ● Product Testing● FDA Filings ● Continuous Improvement ● Written and Verbal Communications● Technical Documentation ● Process Review and Validation ● Regulations Research● Document Control ● Device Modification Review ● Ad Hoc Projects

Bachelor Of Science - Bs, Aerospace Engineering

Successful completion of Cooperative Education Engineering Program with NASA-Johnson Space Center (two terms working in Flight Systems.

Graduate Coursework In Planetary Geology, Elementary Education

Undergraduate Coursework In Mechanical, Aeronautical, And Astronautical Engineering

Began Cooperative Education Engineering Program with NASA-Johnson Space Center (three terms working in Engineering Division).