Emily Keith Email & Phone Number

Saint Paul, Mn, Us

Minneapolis, Mn, Us

Quality Engineer II for the Surgical Wound Management Design Quality Engineering Team supporting both New Product Development and Released Product Engineering • Risk Management File Owner and Design Quality Lead of 9 released product families.• Contributing to design quality engineering for 2 New Product Development projects.• Spearheading risk management process improvements, such as redesigning and standardizing the site's complaint report template and guidance document.• Coordinating intern events and mentoring interns as the Summer 2023 and 2024 Intern Site Lead for 54 total interns.

Minneapolis, Mn, Us

Reliability Engineer I within the Surgical Innovation's Design Quality Engineering Group• Risk management and design quality engineering supporting contact for 16 released product portfolios.• Executed Risk Management EU MDR deliverables for three released product portfolios: Endo Stitch Suturing Device, Stainless Steel Suture, and Endo Close Trocar Site Closure Device. This included transforming Risk Management Plans/Reports, Post-Market Surveillance Plans, Preliminary Hazard Analyses, Complaint Reports, and Risk Analysis Charts. • Contributed to 30 RMF documents outside of my MDR portfolio to support team members.• Authored or collaborated on Risk Management File reviews, Change Development Processes, DFMEAs, PFMEAs, Usability Assessments, Clinical Evaluation Reports, Periodic Safety Update Reports, Instructions for Use, Labeling, Request for Additional Information (RFAIs), and Production Part Approval Processes (PPAPs).• Interfaced with cross-functional teams as the design quality contact on 5 Issue Impact Assessments (IIAs) to discuss root cause investigations and diagnose patient safety impact. I presented the escalated IIAs to leadership teams.• Analyzed internal complaints and identified historical manufacturing trends, isolated issue scopes, gained insights on product and account trends, and developed comparisons to competitor products using the FDA MAUDE database. I generated reports and informed findings to six cross functional teams and several hospitals.• Illuminated a gap between customer needs and a current product by producing literature searches, assessing complaints, and evaluating procedural applications. I spearheaded discussions and proposed a potential Voice of Customer study to eventually engineer a modernized product.• Completed the Medtronic Design for Reliability and Manufacturability (DRM) Greenbelt training course. • Represented my team in the Medtronic Surgical Quality Culture Ambassador program and MWN Lean-In Circles.

Minneapolis, Mn, Us

Department: Surgical Innovations (SI), Gynecological Health, Quality Engineering• Updated the Risk Management Plan, Post Market Surveillance Plan, Preliminary Hazard Analysis, and Risk Analysis Chart.• Generated a Complaint Review and Risk Management File Review.• Ideated and proposed the Virtual Intern Coffee Break Networking Program: During the virtual internship, interns had a desire for more connection. I led a team of 12 interns to organize and plan the networking program where 230 interns voluntarily participated.

St. Paul, Mn, Us

• Developed and improved design documentation, including the trace matrix, design verification and validation protocols/reports, and device drawings.• Refined technical documentation of first article inspections, bill of materials, raw material specifications, and purchase orders.• Executed a competitive product analysis of surgical patient drapes in operating rooms.

Washington, Dc, Us

For the MSSF, I utilized computational fluid dynamics (CFD) to quantify the stress on cells under different simulated microgravity conditions. I also modeled and analyzed fluid/particle motion with ANSYS CFX and SolidWorks.

Atlanta, Georgia , Us

Krishnendu Roy Laboratory for Cellular and Macromolecular Engineering, Department of Biomedical Engineering at Georgia Tech and Emory UniversityI improved and expanded a procedure to fabricate microfluidic devices that replicate the bone-marrow microenvironment in vitro, analyzed the cell behaviors and functions of mesenchymal stem cells, HUVECs, and hematopoietic stem cells in the devices, operated standard laboratory equipment, and followed laboratory safety protocols.Publication: A multi-niche microvascularized human bone marrow (hBM) on-a-chip elucidates key roles of the endosteal niche in hBM physiology https://doi.org/10.1016/j.biomaterials.2021.120683

Bachelor Of Science - Bs, Biomedical Engineering

Biomedical Engineering