RAMANI VENKATESH
Cary,IL
Summary
- Results - oriented professional with experience in handling multiple large-scale projects from initiation to project closure in a regulated medical device industry
- Team leader and mentor with proven ability to foster collaboration with cross-functional teams to successfully deliver complex projects on time and within budget
- Skilled medical device/ healthcare professional with proficient knowledge of FDA, ISO, and EU-MDR requirements
- Project Management Professional (PMP) certified with a Master's degree in Biomedical Engineering
Overview
11
11
years of professional experience
1
1
Certification
Work History
Project/ Program Manager
Cardinal Health
, IL
09.2022 - Current
- Led a team of cross-functional professionals to implement projects for the Corporate Engineering business
- Supervised cross-functional team members in stages of planning, execution, and implementation to deliver projects within scope, timeline, and budget constraints
- Developed project plans including defining project deliverables, milestones, and resource requirements
- Developed comprehensive business cases and project charters for Priority & Alignment on projects to senior leadership.
- Oversaw project advancement, monitored performance metrics, and facilitated milestone and executive reviews.
- Identified risks, conducted risk assessments, and implemented mitigation strategies to minimize project risks
- Collaborated with stakeholders to ensure clear communication, alignment and timely decision making
- Corresponded with external suppliers and manufacturers to achieve project objectives
- Spearheaded diverse initiatives valued at millions of dollars, including manufacturing transformations, product design enhancements, and procedural updates.
- Mentored and coached cross-functional team members, fostering a collaborative environment
- Identified opportunities for improvement within existing systems or processes related to program execution.
- Facilitated change management processes, supporting the organization and stakeholders through project transitions.
Senior Development Engineer
Zimmer Biomet
, Indiana
03.2019 - 09.2022
- Led cross functional team members to support new product development and sustaining engineering project activities
- Managed multiple concurrent projects from concept through production launch stages.
- Conducted tolerance stack-up analysis of critical parts to determine fit and function.
- Supervised and trained junior engineers to the internal company processes and procedures
- Implemented design control requirements on medical devices as per 21 CFR 820, ISO and EU-MDR regulations
- Conducted design reviews, risk reviews and milestone assessments by collaborating with cross-functional team members
- Communicated and collaborated with external suppliers and manufacturers to achieve project objectives
- Facilitated change management initiatives and strategies to support design and process related changes
Development Engineer
Modis Engineering at Zimmer Biomet
, Indiana
07.2016 - 03.2019
- Perform duties and responsibilities of a Design History File lead by carrying out Post Market Development activities for Orthopedic Implants and instruments to meet the FDA regulations of 21 CFR 820
- Develop design assets (User Needs, Design Inputs/Outputs, Verification/Validation) for implementation of design control, risk management and stage gate product development process in accordance with SOP's
- Design 3D CAD models; integrate part models and assemblies of medical devices using Unigraphics NX
- Conduct prior research and carry out root cause analysis to close verification gaps
- Collaborate with Quality Assurance to develop Design Failure Mode Effective Analysis (DFMEA) documentation (Risk management) for the Design History Files
- Create Product Line Engineering (PLE) model for the Knee based Implants and Instruments
- Perform verification testing on medical implants and author testing protocols and reports
- Assess Class I, Class II, and Class III medical devices for compliance and develop electronic design control templates to encompass existing medical devices
- Assess print feature critically by understanding the Geometric Dimensioning and Tolerances (GD&T)
Research Engineer
Defense Research and Development Organization
India
12.2013 - 05.2014
- Worked on the design of lower limb exoskeleton to augment walking and loadbearing capacity for soldiers stationed at a difficult terrain
- Acquired kinesiological parameters mechanically and via MATLAB computations to ensure the functioning of the lower limb exoskeleton
- Stimulated the entire design of the exoskeleton using MSC Adams software
- Tested and compiled reports on all existing lower limb exoskeleton models; documented new design features in the form of a project report
Education
MBA - Engineering Leadership And Innovation Management
Pennsylvania State University
07.2024
Master of Science - Biomedical Engineering
State University of New York
Buffalo, NY06.2016
Bachelor of Science - Biomedical Engineering
Vellore Institute of Technology
06.2014
Skills
- Strategic Planning
- Project Management
- Conflict Management
- Project Development and Lifecycle
- Design Assurance
- Problem Solving
- Critical Thinking
- Project Planning
- Teamwork and Collaboration
- Budgeting and Forecasting
- Data Analysis
- Leadership and Decision making
- Onboarding and Orientation
Certification
Project Management Professional (PMP) - Project Management
Accomplishments
R. Venkatesh, S. Ghosh, and P. Reddy, "Erb's Arm, A mechanical device to assist people with Erb's Palsy in writing," IEEE International conference on Intelligent Systems and Assistive technologies, 978-1-4799-0476-1/13 pp. 32-34, 2013
Timeline
Project/ Program Manager
Cardinal Health
09.2022 - Current
Senior Development Engineer
Zimmer Biomet
03.2019 - 09.2022
Development Engineer
Modis Engineering at Zimmer Biomet
07.2016 - 03.2019
Research Engineer
Defense Research and Development Organization
12.2013 - 05.2014
MBA - Engineering Leadership And Innovation Management
Pennsylvania State University
Master of Science - Biomedical Engineering
State University of New York
Bachelor of Science - Biomedical Engineering
Vellore Institute of Technology
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