Alex Mcmullen Email & Phone Number

Rochester, Ny, Us

Rochester, New York, United States

Buckley Soft Tissue Biomechanics Lab (joined lab in June 2021)Advisor: Mark Buckley, PhD

Rochester, New York, United States

myHub URBEST Program Overview:https://www.urmc.rochester.edu/education/graduate/myhub-professional-development/urbest-career-services/myhub-urbest-program-overview.aspx

Rochester, New York, United States

• Intro to Quality Engineering (Spring 2022 - Jan. 2022 to Mar. 2022)• Intro to Quality Engineering (Spring 2021 - Feb. 2021 through Mar. 2021)

Rochester, New York, United States

Center for Medical Technology & Innovation (CMTI), Class of 2021• Completed an 8-week clinical practicum with a focus in orthopaedics, observing more than 25 surgeries at the University of Rochester Medical Center (URMC).• Collaborated with surgeons and OR staff to identify unmet clinical needs, and transformed them into Biodesign statements.• Assessed clinical needs based on factors such as voice of customer (VoC) feedback, stakeholder analysis, market analysis, and evaluation of the regulatory, reimbursement and technical landscapes. • Presented the top 3 most promising clinical needs to a panel of external reviewers, and ultimately selected one need to pursue for the CMTI capstone/design project.

Greater Pittsburgh Area

• Worked with the Program Management department to introduce a new product lifecycle management process into the Omnicell global QMS; included talking with various stakeholders across the organization to perform a gap analysis with current Omnicell processes.• Reviewed Product Requirements and Design Verification & Validation (V&V) documentation/activities for the next generation IV compounding robot (IVX Station - Class II Medical Device).• Instrumental in transitioning the IVX Station program (Class II Medical Device) to the company’s new product lifecycle management process, including working with the project manager to capture, categorize, and track all action items that are necessary to ensure compliance to design control regulations.• Collaborated with development engineers to ensure that all equipment and custom test fixtures used for design verification were calibrated or inspected, and in compliance with Omnicell procedures.• Spearheaded an effort to create a Labeling Requirements Matrix, a labeling development procedure, and a symbols glossary for Omnicell Medical Devices; included conducting thorough research of labeling regulations/standards from FDA, ISO, and IEC.• Created guidance and drafted QMS procedure for risk-based statistical sample size determination for design V&V testing.• Assisted the Marketing team in documenting User Needs for the IVX Station (Class II Medical Device), and ensured traceability from those User Needs to Product Requirements.

Dover, Ohio

• Collaborated with cross-functional teams to complete issue evaluations, initiate Quality Holds and Health Hazard Evaluations, investigate manufacturing non-conformances, and implement process improvements for the Capital Equipment and Servicing/Repairs departments.• Created and implemented tools and methods for actively/semi-autonomously tracking and trending non-conformance and rework data for the Capital Equipment department.• Developed and proposed a new method to track and trend “common-cause” manufacturing non-conformances, which would automatically trigger investigation/root cause analysis if an issue exceeded a normalized threshold.• Led an effort to provide Manufacturing, Servicing, and Quality input to the New Product Introduction (NPI) team for the design of a new medical device.• Successfully led a Corrective and Preventative Action (CAPA) investigation and associated implementation activities as the CAPA owner. The CAPA was related to a high-risk problem that resulted in a medical device recall.

Warsaw, Indiana / Dover, Ohio

The Quality Development Program features three, eight-month rotations in different areas of Quality and Regulatory Affairs.Rotation 3: Quality Assurance (Operations)Surgical Division | Dover, OH | Oct 2017 - Jun 2018• Contained, investigated, trended, and reported on non-conforming products for the Capital Equipment and Servicing/Repairs departments.• Responsible for gathering, analyzing, and reporting monthly metric data for capital equipment rework and repairs.• Worked with Manufacturing Engineers to implement new operating/testing procedures, process improvements and quality controls during the integration of a new product line.• Collaborated with Supplier Quality and vendors to determine root causes of supplied component failures.Rotation 2: New Product Introduction (NPI) Regulatory Affairs Surgical Division | Dover, OH | Feb 2017 – Oct 2017• Executed regulatory responsibilities necessary to release a new line of Surgical Saw Blades. Responsibilities included performing a regulatory analysis, collecting device attributes, and leveraging clinical research literature to ensure the new products met regulatory requirements prior to product launch.• Supported the remediation of Risk Management Files (DFMEA & PFMEA) for all Zimmer Biomet Surgical products; collaborated with interdisciplinary teams to ensure that Risk Management files are compliant with ISO 14971:2012.Rotation 1: Post-Market SurveillanceReconstructive Division (Knees Segment) | Warsaw, IN | Jun 2016 – Feb 2017• Investigated consumer complaints/legal claims, and responded to regulatory inquiries for all knee products.• Performed root cause analyses and risk analyses of prosthetic knee implant and instrument failures.• Gathered and analyzed complaint data for CAPAs, legal cases, and Post-Market Surveillance plans.

Ada, Ohio

Conducted biomechanics research for Dr. Hui Shen, Professor of Mechanical Engineering. Research projects included "Mechanics Analyses of Boxer’s Fracture" and "Finite Element Analysis of Osteotomy Treatment for Kienbock’s Disease". See the Projects and Publications sections for more details.

Warsaw, Indiana

• Researched and developed Methods and Systems for Stitching Soft Tissue to Bone (see Patents section). Responsible for the proof of concept testing (including a cadaver lab study) to demonstrate the feasibility of the concept to management. I also generated the initial 3-D models and prototypes for the system; started to draft some early-stage design requirements; and researched surgical procedures that could utilize the method.• Performed an extensive shelf life (accelerated aging) study for a disposable component of a prototype medical device.• Utilized an industrial high-speed camera and ProAnalyst Motion Analysis Software to gather information on the general behavior and performance of prototype medical devices.• Conducted various laboratory tests to determine the effects of cleaning on prototype medical device components.• Performed finite element analyses (FEA) to determine the durability of various prototype medical device components.• Generated and analyzed 3-D models in SolidWorks.• Created a weighted 3-D printed model of a medical device prototype that simulated the goal weight and center of mass of the actual device to demonstrate to surgeons how the device will “feel”.• Quoted, printed, and cleaned 3-D printed parts as requested in the Zimmer Rapid Prototyping Lab.• Performed maintenance and cleaned the Objet 500V 3-D printer in the Zimmer Rapid Prototyping Lab.

Warsaw, Indiana

• Maintained master data elements within the SAP Plant Maintenance System (Title 21 CFR / Part 11 validated system), which included creating and updating asset equipment records as required by change control policies.• Revised global asset management forms used to create asset records and change control of capital assets.• Reconciled business unit number discrepancies between the JDE Financial System and SAP Plant Maintenance System as identified by a fixed asset audit and a regulatory agency audit.• Worked with a team of manufacturing engineers and production maintenance engineers to develop a process-specific form to document thermal processes of heat treatment equipment used to manufacture medical implants.

Findlay, Ohio

• Designed and built a custom conveyor system to automate a job step, thereby eliminating a process bottleneck.• Assembled a control panel and programmed a PLC to automate a trap door part catcher system to separate defect parts.• Designed and prototyped a custom gaging system for a production wire bending machine.• Designed, 3-D modeled (Autodesk Inventor), prototyped (3-D printed) and implemented various tooling, jigs, and poka-yoke fixtures for machines on the manufacturing floor.• Responsible for the creation and revision of operator work instructions used on the manufacturing floor.

Doctor Of Philosophy - Phd, Biomedical Engineering

Master Of Science - Ms, Medical Technology & Innovation

Activities and Societies: Center for Medical Technology & Innovation (CMTI)

Bachelor Of Science - Bs, Mechanical Engineering

Activities and Societies: Northern Entrepreneurs’ Organization (NEO); Innovators of Ohio Northern (ION); Polar Robotics; Northern.