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Meet Olivia

Olivia Hillrich

Systems Engineer

Ms. Hillrich is a systems engineer with a background in biomedical engineering. As a systems engineer, she supports multi-disciplinary teams in the design, development, testing, and post-market maintenance of medical devices by leveraging her expertise in safety and security risk management, requirements development, verification, and validation. She has supported a variety of medical devices including a junctional tourniquet, brain impact protection system, and diagnostic infusion system spanning phases of concept design and fabrication, testing, transfer to production, and sustaining engineering. She also has experience in pre-clinical pharmaceutical safety assessment, workplace ergonomics, and technical laboratory instrumentation related to bioanalytical chemistry, mechanical product testing, and thermal analysis.

Skills Summary

  • Engineering Product Design & Development
  • Team Leadership
  • Technical Laboratory Instrumentation
  • Requirements Development
  • Safety and Security Risk Management (ISO 14971, SW96)
  • Design Verification and Validation (V&V)

Professional History

Position Summary: CMD MedTech provides systems engineering, project management, and design and development services to the medical device and healthcare industries. Ms. Hillrich provides systems engineering and product development support to clients.

Systems Engineer for Electro-Mechanical Products: CMD MedTech provides systems engineering support for multi-disciplinary, electro-mechanical products including a combination product used to infuse a diagnostic imaging agent into patients and a medical device used to insufflate the colon – both of which are used as precursors to diagnostic imaging (PET and X-Ray/CT). As a systems engineer supporting sustaining engineering for these US / OUS systems, Ms. Hillrich supports safety and security risk management activities, requirements development, verification / validation, and preparation of submission content. Additionally, she supports post-market maintenance activities including ongoing cybersecurity management activities and risk-related updates driven by incoming field data.

Systems Engineer for a Mechanical Product: CMD MedTech provides systems engineering support for a mechanical system designed to help protect the brain from the effects of repetitive head impacts. As a systems engineer supporting sustaining engineering for this system, Ms. Hillrich supported verification efforts including drafting verification protocols, executing verification testing, and generating final reports to summarize test results.

Intern Supporting Mechanical Product Development: Ms. Hillrich supported the development of a junctional tourniquet device. Her primary responsibility was the development of the Design and Development File in preparation for 510(k) submission. Additionally, she actively collaborated with external design, testing, validation, verification, manufacturing, and distribution partners during the device development process.

Student Teaching Assistant for Engineering Students: Ms. Hillrich guided college first-year engineering students through laboratory experiences spanning a variety of engineering disciplines. She was responsible for evaluating students’ technical writing and communicating feedback clearly. Additionally, she served as a team leader during both transitions from in-person to virtual instruction, and back to the classroom upon students’ return to campus as required due to COVID-19. These leadership roles required oversight of teams of 10-15 other teaching assistants, with the goal of developing new or updating existing course curriculum.

Prosthetic Development Workshop Volunteer: Ms. Hillrich collaborated with Columbus design and engineering peers to develop a fit-for need prosthetic for a young girl. Over the course of the 6-week workshop, she worked closely with the recipient to develop a hand prosthetic that would allow the recipient to participate in volleyball, in addition to other activities, at her school.

Technical Applications Support Intern: Ms. Hillrich conducted analyses with laboratory instrumentation in an effort to develop methods for use by potential customers of analytical instrumentation. She was responsible for ensuring that customer products would be compatible with analytical instrumentation, including pH meters, titrators, dynamic mechanical analyzer (DMA), thermogravimetric analyzer (TGA), and differential scanning calorimeter (DSC).

Environmental, Health, & Safety Intern: Ms. Hillrich developed an ergonomic risk-assessment tool for departments experiencing high rates of musculoskeletal discomfort. She met regularly with department supervisors and shadowed relevant departments, during the process of developing the excel-based tool.

Bioanalytical Chemistry Intern: Ms. Hillrich performed sample analyses in the field of pre-clinical pharmaceutical safety assessment. These analyses required mass spectrometer evaluation of small and large animal biological samples in order to evaluate the timeline of drug metabolism through each animal model.

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