Erin Fitzgibbons

812-***-**** ad4hg5@r.postjobfree.com https://www.linkedin.com/in/erin-fitzgibbons/

ENGINEER

Engineer with skills in product design, testing, and risk management; experienced working as a post-market sustaining engineer, R&D engineer, and test lab engineer incorporating standards and user experience into technical writing and engineering documentation in areas ranging from the manufacturing floor to cross functional training materials. Looking to transition to environmentally-focused role in a larger city.

KEY SKILLS

Product Development Managed Contractors and Co-ops Project Management

UN and DIR Development Bench Testing and Protocol Development Life Cycle Analysis (LCA) Biocompatibility Risk Documentation (HA, FMEA, Complaint Analysis) Statistics (Minitab) Useability Engineering CAD Process and Test Method Validation

PROFESSIONAL EXPERIENCE

Cook Medical Urology, Spencer, IN January 2019 - June 2023

Sustaining Engineer II

Led 5 projects for EU MDR remediation while reviewing, supporting, and coordinating work of up to 5 contractors, and led 9 projects updating labeling for FDA 510k remediation on various urological devices.

•Experienced with engineering documentation: worst-case/representative testing for validation and verification, user specification, CEA (Clinical Effects Analysis), BRA (Benefit Risk Analysis), HA (Hazard Analysis), FMEA (Failure Modes and Effects Analysis), Design Control Traceability Tables (DCTTs linked sources, needs, requirements, and testing).

•Provided engineering support to various post-market design changes, including dimensional, material, process, CAPA, and labeling changes by conducting feasibility testing, working cross-functionally, and implementing the changes into production. Device updates were intended for MDR compliance and device improvement to align with state of the art devices using user feedback, regulatory standards, and complaint and non-conformance trends.

•Developed and presented training materials in various areas of subject matter expertise, ranging from nitinol engineering to kidney stone devices and procedures.

•Evaluated potential product improvement options using cost-benefit analyses leading to a potential reduction in head count and improved takt time for nitinol wire processing.

•Reviewed updates to drawings and various other documents for quality to implement improvements in manufacturing and supply chain.

•Implemented changes to MIs (Manufacturing Instructions) and QC (Quality Control) instructions to align with knowledge and existing practices of the production floor.

•Mentored several Co-ops by providing training and project guidance leading to one joining full time.

Cook Medical, Bloomington, IN Summers of 2014 – 2018

Summer Intern

Performed various summer internships that included working as a test method validation engineer intern, Otolaryngology / Head and Neck Surgery R&D intern, process validation engineer intern, and Engineering Testing Lab summer hire.

•Determined representative samples for a laser scan micrometer method TMV and evaluated MIs and QC instructions for consistency and clarity to propose changes for a wire guide checker TMV as a test method validation engineer Intern.

•Conducted product research for a medical device to treat chronic rhinosinusitis using clinical literature, MAUDE, and user feedback to develop user needs, DIRs, design parameters, CEA, and UFMEA as an Otolaryngology / Head and Neck Surgery R&D intern.

•Developed and performed IQ, OQ, and PQ for Cap and Adapter and Machined Parts Cleaning processes and conducted characterization study of power supply impacts electric torque driver output as a process validation engineer intern.

•Performed bench testing, inventory, archival, and equipment calibration / labeling as an Engineering Testing Lab summer hire.

Weed Wrangle, Bloomington, IN 2023

Volunteer

•Volunteered to help rescue public parks and green spaces from invasive, non-native species through removal of especially harmful trees, vines, and flowering plants.

•Learned methods of maintaining an area free of non-native invasive plants and encourage replanting with natives in removal areas including public outreach and GIS.

EDUCATION

Bachelor of Science (BS), Engineering - Multidisciplinary engineering with mechanical engineering emphasis - Minor in Sustainable Engineering

Purdue University, West Lafayette 2014 – 2018

•Python, Matlab, and statistics experience

•Boiler Green Initiative (BGI) to enhance sustainability on campus.

•Women in Engineering Program (WIEP) - Mentored first year engineering students.

•Engineering Projects in Community Service (Purdue EPICS)

•Global Alternative Power Solutions Team - Lead 5 students to design, prototype, and build a solar panel system for demos at Purdue.

•Children’s Educational Demonstrations Team - Lead 5 students to design and build an interactive earthquake shake table for the Indianapolis Children’s Museum.

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