Andrea Ciolko Email & Phone Number

Salt Lake City, Ut, Us

Salt Lake City, Utah, United States

Windows OS:Lead a team of software engineers in the full software development lifecycle for all the BIOFIRE® IVD and Non-IVD product lines. This includes configuring and hardening the Windows operating systems and creating a custom computer image to deploy the software to the system computer and leading the Windows patch management program. Responsible for computer component end of life management and software deliverables. Cybersecurity:Create and maintain a brand new portfolio of customer-facing cybersecurity documentation ( i.e. MDS2, SBOMs, Product Security whitepapers) that highlights the cybersecurity profile for BIOFIRE® products and is critical for regulatory submissions. Lead cybersecurity vulnerability monitoring and evaluation for BIOFIRE® products including assessing risk and implementing mitigations. Work with third-party cybersecurity consultants to perform frequent assessments on BIOFIRE® products with the following deliverables: System Architecture Risk Analysis, Penetration Testing, Threat Models, and Component Diagrams.

Salt Lake City, Utah, United States

Sustainment Engineering for the BioFire FilmArray Instrument which uses multiplex PCR technology for syndromic infectious disease testing.- Sustained current product lines of the FilmArray Instrument- Design Changes- Improved manufacturing capabilities, first pass yield, and efficiencies- New products transferred from design to manufacturing

Greater Salt Lake City Area

Process improvements, engineering design transfers, cost saving projects, and new product introductions for mobile c-arms within GE Healthcare's Surgical Imaging division.

Medina, Ny

- Post market surveillance for Baxter Sigma Spectrum Infusion pumps to monitor device performance and detect potential device-related safety issues.- Effectively communicated with customers and the internal technical support team, service, and engineering departments to ensure accurate complaint investigations were performed.- Provided critical inputs for risk analysis, CAPA, and new product development.- Submitted medical device reports to the FDA following reporting regulations (21 CFR 803 and 820).- Participated in cross-departmental engineering projects and cross-facility complaint improvement initiatives.- Provide a high level of customer support and service through quickly and efficiently resolving complaints.

Buffalo/Niagara, New York Area

- Assembled Hand Control and Suction Ablators for use in arthroscopic surgeries- Tested continuity of rods- Tested Suction Ablator tubing for leaks- Followed ISO Standards

Buffalo/Niagara, New York Area

Company Goal: Eliminate allogeneic bone marrow transplants and improve homologous transplants by developing new sources of hemogenic cells for hematopoietic system regeneration to treat patients with blood diseases and blood cancers. - Performed the prospective isolation of hematopoietic stem cells and other cell types from umbilical cord blood- Studied the regenerative properties of the isolated cells in vitro and in vivo

- Investigated the electrochemical interactions on the surface of commercially pure titanium- Conducted in vitro experiments that better replicate in vivo experiments when titanium is used in orthopedic implants

Observed daily office visits and routine proceduresViewed both knee and shoulder arthroscopic surgeries