Aurora Hill

Aurora Hill

BIO

Aurora Hill, Director of Engineering

Ms. Hill is a biomedical engineer with over 10 years of experience in developing new medical technologies for commercialization. She has helped bring new medical devices to market for large corporations, mid-size firms and start-up companies, and she has been exposed to medical technologies in several therapeutic areas such as respiratory care, orthopedics, gastroenterology and neurology. In addition to Aurora’s technical experiences, she also has substantial experience leading cross-functional teams through the development process. As such, she has led project teams through the evaluation, development and implementation of product solutions to optimize manufacturing quality and product performance.

Aurora holds a Bachelors of Science in Biomedical Engineering from North Carolina State University with a minor in mathematics, and she holds a Masters of Science in Biomedical Engineering from Duke University. In addition to her technical credentials, she also holds a MBA from Emory University’s Goizueta business school with an academic focus in finance.

Aurora’s vast professional and academic experiences equip her with valuable insights that help customers navigate the complexities of the medical device product development roadmap.

Services

Aurora’s primary areas of expertise include medical device product development and project management.

Project Management
  • International project team management
  • Budget, timeline, resource management
  • Project feasibility assessment
Product Exposure
  • Deep brain stimulator
  • Nerve stimulators
  • Feeding tubes and placement systems
  • Endotracheal tubes and placement systems
  • Closed suction catheters
  • Percutaneous dilatational tracheostomy systems
  • Orthopedic drill
  • Contact lenses
  • Intrauterine visualization device
Technical Documentation
  • Stakeholder requirements
  • Performance specifications
  • Process development protocols and reports (IQ/OQ/PQ)
  • Manufacturing procedures and work instruction
  • Design verification protocols and reports
  • Design validation protocols and reports
  • Human factors validation protocols and reports
  • Failure mode effects analysis (design, use, process)
  • Design review records
  • Clinical testing protocols and reports
April 2017: Secure BioMed Evaluations
  • Project management
  • Technical DHF documentation
  • Design validation/verification support
  • Process qualification support
June 2015: SynerQ
Senior Consultant

Managed $4M project and led cross-functional teams in the execution of process validation efforts for six high volume manufacturing processes.

July 2011: Halyard Health (formerly Kimberly-Clark Healthcare)
Product Development Engineer

Served as global technical leader and project manager for respiratory platform and led the evaluation, development and implementation of product solutions to optimize manufacturing quality and product performance. Analyzed technologies for acquisition and collaborated with marketing, finance and sales to develop business cases in support of business development activities. Led design input, design output, design verification and validation, and design transfer projects for respiratory health and gastroenterology products.

November 2009: Femasys
Project Engineer

Led multi-functional teams from product conceptualization through commercialization for two new gynecological medical devices. Improved company’s intellectual property by researching existing patents, writing technical explanations for new medical device designs, and creating and testing prototypes to prove new concepts.

January 2009: Remington Medical
Product Development Engineer

Developed and executed process validation and design verification protocols, and collaborated with customers and suppliers to create product and process specifications. Assessed risks and risk mitigations associated with medical device design and manufacturing processes to provide technical guidance for complaint investigations, sampling plan determination, and design changes.

June 2008: Specialty Underwriters Group
Technical Account Leader

Managed the administration of maintenance and repair services to the customer, a multi-billion dollar pharmaceutical company, and aided in bid and proposal effort by translating feedback from of the customer into elements of a request for proposal response. Analyzed and resolved issues with outstanding invoices to ensure that vendors were paid in a timely manner.

June2006: AVOS Life Sciences
Biotechnology Consulting Intern

Identified physicians and conducted physician interviews for pharmaceutical market research and opportunity assessment. Researched the investor style dynamics and formulary positioning for the top 14 pharmaceutical companies.

  • M.B.A., Finance Concentration (December 2016)

    Emory University, Goizueta Business School, Atlanta, GA

  • M.S. Biomedical Engineering, Neuroengineering Concentration (May 2008)

    Duke University, Durham, NC

  • B.S. Biomedical Engineering, Minor in Mathematics – Magna Cum Laude (May 2006)

    North Carolina State University, Raleigh, NC

Aurora Hill

7828 Hickory Flat Highway, Suite 120, Woodstock, GA 30188

(770) 837-2681

800-361-0945

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