Rudhramoorthi B
Chennai
Summary
Results-driven Mechanical Engineer with 7 years of experience in the medical device industry, specializing in orthopedic implants and reusable surgical instruments (knee, hip, and shoulder). Proven expertise in 3D CAD modeling (SolidWorks, Creo), GD&T, tolerance stack-up, and PLM systems. Skilled in applying ISO 13485 QMS and ISO 14971 risk management principles to ensure regulatory compliance and patient safety. Adept at delivering innovative, manufacturable, and cost-effective solutions, with a track record of process improvements (VBA automation, Lean/Six Sigma) that reduced cycle times and improved efficiency.
Overview
7
7
years of professional experience
1
1
Certification
Work History
Team Lead
01.2024 - Current
- Led a cross-functional team in the successful design and transfer of Knee Femur Implants, ensuring compliance with ISO 13485 and ISO 14971 standards.
- Served as the primary liaison with customers and clinical teams, gathering requirements and delivering regular project updates to align expectations.
- Managed end-to-end project timelines, tracked milestones, and ensured on-time completion of deliverables.
- Partnered with manufacturing and quality teams to resolve production challenges and support seamless design transfer.
- Mentored junior engineers on design documentation, drafting practices, and PLM system usage, strengthening team capability and efficiency.
- Project: Leadership & Project management
Design Engineer
01.2021 - 01.2023
- Designed and updated reusable surgical instruments supporting total knee arthroplasty procedures, ensuring precision and usability in clinical settings.
- Developed detailed engineering drawings with proper GD&T to guarantee manufacturability and functional reliability.
- Collaborated with Quality and Regulatory teams to maintain strict compliance with ISO 13485 standards throughout the design lifecycle.
- Prepared user manuals (IFUs) and created 2D technical illustrations to support surgical teams and enhance product usability.
- Supported risk management activities
- Project: Hip Replacement Instrument Set Development
Junior Design Engineer
01.2019 - 01.2020
- Supported design and development of knee implants and reusable surgical instruments, contributing to early-stage product innovation.
- Created 3D CAD models and engineering drawings in SolidWorks/Creo under senior engineer guidance, ensuring accuracy and manufacturability.
- Applied GD&T principles to guarantee proper fit, alignment, and functional reliability of assemblies.
- Performed tolerance stack-up studies to validate part assemblies and ensure manufacturability in production.
- Maintained design files and change records using PLM tools, ensuring traceability and compliance with design control processes.
- Assisted in early-stage risk assessments and actively participated in internal design reviews, gaining exposure to ISO 14971 risk management practices.
- Project: Primary Knee Implants and Instruments
Education
B.E - Mechanical engineering
01.2019
GPA: 7.5 CGPA
Skills
- 3D CAD Modeling & Engineering Drawings (SolidWorks, Creo)
- GD&T & Tolerance Stack-up Analysis
- Design Control & Risk Management (ISO 14971)
- PLM Systems & Documentation Control
- Quality Management Systems (ISO 13485)
- IFU & Labeling Documentation
- Cross-functional Project Leadership
- Manufacturing & Quality Collaboration
- Team coordination
Accomplishments
- Accelerated mass/volume data extraction from CAD models (DJQ): Created a VBA-driven workflow to capture part volumes from SolidWorks, cutting effort by ~25% and improving consistency across assemblies.
- Optimized SKU attribute updates via change orders: Automated bulk updates and checks with VBA, achieving ~20% faster turnaround while improving documentation accuracy.
Certification
VA/VE certified professional skilled in optimizing product value by enhancing function and reducing cost (SAVE International CVS®)
Timeline
Team Lead -
01.2024 - Current
Design Engineer -
01.2021 - 01.2023
Junior Design Engineer -
01.2019 - 01.2020
Sri Sairam Institute of Technology - B.E, Mechanical engineering