Sajith Anantharaman

• Managed the design and documentation of NM/PH therapy leads, ensuring adherence to FDA regulations and facilitating seamless transfer to manufacturing, now utilized in market for 5+ years.
• Lead detailed design activities: VOC, Concept development, dFMEAs, FEA, drawing reviews, tolerance stack-ups and manufacturing transfer.
• Applied DRM principles to burn-down risk for projects including: ANOVA, DOE, capability analysis, montecarlo, tolerance calc, DFM for assembled, molded, machined, extruded components.
• Steered ross-functional collaboration in detailed design, integrating DRM principles to resolve 5 high-risk project issues; findings led to innovative solutions preventing field corrective actions.
• Championed intern hiring, performance and early career engineers by providing guidance on Medtronic culture, design principles and career trajectories.
• Defined project scope and objectives for AOP planning initiatives valued under $7 million, contributing to optimized strategic resource allocation.
• Managed a team of 5 employees to implement a new method of Peer Recognition in the company resulting in great success since FY22.
• Served as POC for customer tours including HCP, sales reps, DM's.
• Lead test engineer planning activities including: managing resources, scheduling, carry out IQ, OQ, TM, TMV and DVT activities.
• Lead remediation efforts, second sourcing, supplier transfer projects including planning and execution resulting in on-time FDA submission.

• Managed continuous Improvement R&D activities to improve the design and testing of EP catheters following FDA regulations and ISO standards.
• Improved reliability of marked launch devices including: review of customer requirements, design control evidence documents, production support to address remediation gaps.
• Reviewed, updated dFMEA Analysis of ablation catheter and identified CTQ that resulted in successful qualifications.
• Applied Minitab to analyze DV testing data, including hypothesis testing to identify potential improvements, resulting in design changes to improve product performance.
• Carried out tolerance stack-up analysis of drawings and initiated design changes.

Helped with FEA analysis of surgical tools in ANSYS including the following.

• Prepared more than 350 input files for various designs.
• Created model geometry in CREO as needed.
• Documentation in accordance with good documentation practices (GDP) in an FDA environment, ISO standards.
• Analyzed results data to determine model correlation to physical test data.

Tutored 36 graduate students in Structural Dynamics.

• Topics covered include Vibrations, Modal analysis, Modeling Single DOF, Multiple DOF and FEM using MATLAB.
• Assisted faculty member with classroom instruction, exams, record keeping, and other miscellaneous projects.

• Wrote numerical modeling code using MATLAB to generate STL file for 3D Printing.
• Manufactured bone structure using bio based material in a 3D printer – FDM and carried out DOE.
• Carried out tension, compression tests for characterization.

• Designed new fixture using Creo, FEA for reducing setup time of boring machine by 30minutes.
• Coordinated material management in production using SAP including BOM management and creation of traceability files (DHF).
• Troubleshooted issues on production floor using DMAIC methodology including A3, 5Why’s, Fishbone diagram.
• Conducted tolerance analysis up for assemblies and applied GD&T principles to parts – ASME Y14.5.