Brian Lovato

Senior Engineering Manager, Disposables R&D at Haemonetics Corporation
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Contact Information
us****@****om
(386) 825-5501
Location
Greater Chicago Area

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5.0

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Kaitlin Leveille

Brian is an intelligent, skilled and thoughtful leader. He is both a coach and problem solver. I admire Brian’s ability to share a diverse perspective using a firm but kind approach. He consistently proves that he has a command of the subject matter he is involved with, offering strategic program management to his business partners.

Ranee Stile, Ph.D.

When we were both at Baxter, I worked directly with Brian, and it was an absolute pleasure! First, Brian is funny, kind, considerate, and friendly. He is an incredibly hard worker, with an amazing work ethic. He is trustworthy, and he has impeccable integrity. He has incredibly effective communication skills, at all levels of the organization. Whether he is talking to laboratory technicians, project peers, or upper management, he is thoughtful in his tone, and he explains all topics in a manner that everyone can understand. He is always approachable and available to answer any questions, and he never fails to follow-up, if he needs more information to answer appropriately. His critical-thinking and problem-solving skills are exceptional. He never shies away from a challenge, and he is committed to doing the right things the right way. He is a dedicated and reliable team member and peer. I can honestly say that I was always thrilled when I knew I would be working with Brian on a project. And I had so many good things to say about Brian that my manager actively tried to recruit Brian to join our team! I would highly recommend Brian for any job or project, not only based on his impressive technical acumen but also based on the extraordinary person he is.

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Credentials

  • Agile Foundations
    LinkedIn
    Mar, 2021
    - Nov, 2024
  • Lean Six Sigma Green Belt Certification
    Baxter International Inc.
    Jan, 2009
    - Nov, 2024

Experience

    • Senior Engineering Manager, Disposables R&D
      • Jan 2023 - Present

    • United States
    • Hospitals and Health Care
    • 700 & Above Employee
    • Senior Device Program Manager
      • Jul 2021 - Dec 2022

      Kidney Care, a CVS Health Start-up, aims to provide an environment to support Home Hemodialysis for patients suffering from End Stage Renal Disease (ESRD). My contribution to this mission is to provide program management for the build-out of a CVS Technical Operations Organization focused on the service and distribution needs of a new Home Hemodialysis (HHD) device. Specific contributions include leading program planning and developing roadmaps, project execution management by deploying Agile methodologies, leading technical development and knowledge transfer discussions with third-party vendors, and providing strategic and technical consultation to my stakeholders in Engineering, Field Service, Quality Management, and Supply Chain. [Thoughts expressed are of my own and do not represent CVS Health.] Show less

    • United States
    • Medical Equipment Manufacturing
    • 700 & Above Employee
    • Senior Principal Engineer - Global Operations
      • 2017 - 2020

      Baxter had developed a centralized support model for process and operations sustaining expertise. As a Global Operations team member, I managed various initiatives focused on Regulatory Compliance, Product Sustainability, and Value Improvement. Notable contributions include:+ Directed a team of 10+ engineers and technicians in evaluating Elastomeric pump flow rate accuracies in support of device design changes to address an FDA 483 observation.+ Managed an offshore internal engineering team focused on product sustainability for both the Renal PD Disposables and Elastomeric pumps portfolios.+ Led a program utilizing offshore external resources to address global standard work change controls supporting Life Cycle Management initiatives for 6 Global Business Units.+ Implemented Capital Value Improvement Project (VIP) qualifying an alternate part supplier leading to $500K+ in annualized savings.Additional contributions included leading a design transfer initiative to a 3rd party contract manufacture, developing business cases for cost-savings proposals, and managing several global VIP projects of varying complexity. Show less

    • Senior Principal Engineer - Elastomerics R&D
      • 2013 - 2017

      Elastomeric pumps are medical devices that allow for patients to receive ambulatory treatment for such therapies as chemotherapy, antibiotics, or localized pain management. As an R&D team member, I supported the initiative to transfer and remediate the Design History Files (DHF) for Baxter’s Elastomeric pumps portfolio. Listed below are a few notable contributions that led to the lifting of an FDA Warning Letter.+ Directed the Intermate Product Design Verification workstream managing 15+ external engineering resources completing DHF remediation milestones a month early.+ Managed the successful development, installation, and validation of a computerized flow system capable of evaluating Intermate flow rate accuracy.+ Technical lead for multiple Test Method Validations (TMV) enabling product verification testing of Elastomeric products.Following DHF remediation, I oversaw the Intermate product design as Product Design Owner (PDO). In this role, I managed the DHF, addressed field complaints, responded to customer product use questions, and was the Technical Approver on design-related changes. Additionally, I served as CAPA lead on several investigations. Guided by the DMAIC approach, I successfully resolved CAPAs addressing in-transit product damage and particulate matter product contamination. Show less

    • Principal Engineer – Medical Products Device
      • 2009 - 2013

      Within this Operations role, I led a variety of sustaining engineering projects supporting the Renal Homechoice PD Disposables and Medication Delivery Access Systems product portfolios. Projects ranged from supplier changes to raw materials, Value Improvement Projects (VIP), resolving product non-conformities, and Corrective Action Preventative Action (CAPA). Of note, I led a global, cross-functional team in qualifying a supplier change to a resin avoiding a supply disruption. This change impacted hundreds of products across multiple businesses and manufacturing facilities. Show less

    • Senior Engineer – Non-PVC Delivery Systems, Medication Delivery Division
      • 2006 - 2009

      As a Non-PVC container team member, I supported the development, launch, and post-market sustaining efforts for US AVIVA Large Volume Parenteral (LVP) solution container systems. Of my contributions, I am most proud of having conducted various DOE studies to optimize cast film and tubing processes, having investigated material defects and having led initiatives to qualify alternate materials. Additionally, I supported the product development of a high pH drug container system and various sustaining product initiatives for the INTRAVIA product line. Show less

    • Product Development Engineer - Renal R&D
      • 2005 - 2006

      A focus on preventing touch contamination led Renal R&D to create a new way of connecting to Peritoneal Dialysis (PD) therapies. In this role, I supported the product development of this new PD connection system leading to a 510(k) submission for several different product codes. Leveraging my analytical and materials science skills, I conducted various design-related investigations addressing component bonding, environmental stress cracking, and particulate matter defects.

    • United States
    • Hospitals and Health Care
    • 700 & Above Employee
    • Validation Engineer – Abbott Diagnostic Division
      • 2004 - 2004

      I joined a team tasked with standardizing and evaluating system suitability for various immunoassays. Abbott had entered into a consent decree with the FDA preventing the sale of immunoassay tests used for diagnosing hepatitis B, hepatitis C, HTLV-I/II, and other infectious diseases. In this role, I helped to develop an internal stability program for immunoassay standards, evaluated numerous immunoassay system validations, and co-authored a statistical tool training manual. This effort aided in the return of several diagnostic products back into the US market. Show less

    • United States
    • Medical Equipment Manufacturing
    • 700 & Above Employee
    • Research Engineer – Transfusion Therapies R&D
      • 2003 - 2003

      As a Research Engineer, I conducted product design verification tests for the INTERCEPT Pathogen Inactivation system. My contributions led to a further understanding of the activator pouch design used for the Pathogen Inactivation of Platelets therapy. Noteworthy contributions include the evaluation of Luer lock integrity under varying torque ranges, chemical resistance of the activator pouch, and DFMEA inputs for the activator pouch. This product is currently offered under the Cerus Corporation and serves the world by reducing the risk of infusion-transmitted infections. Show less

Education

  • Michigan State University
    BS, Materials Science & Engineering

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