Jayaram Abimanyu
Chennai
Summary
Medical device engineering professional with about 13 years of experience having handled design, development and production of Ophthalmic microscope and its accessories in an OEM, handled DCRM, PRM and Process validation support projects for Orthopedic manufacturing client for about 4 years, handled design verification and validation testing of class III active implantable medical device for about 3 years and currently managing medical device project delivery management for customers based out of North America, responsible for client management, technical process management, project management for about 2 years and therefore having almost 22 years of experience in medical domain both in OEM and Service Industries.
Overview
24
24
years of professional experience
1
1
Certification
Work History
Technical Manager
Actalent – Allegis Services (India) Pvt. Ltd
Chennai
01.2022 - Current
- Leading and managing medical device product engineering team in the delivery of customer focused products and services
- Responsible for client management, technical management, project management and resource management
- Governance meeting with internal stakeholders and client leadership team
- New business development and account management
- Responsible for P&L of multiple accounts
- Responsible for customer satisfaction reviews and corrective actions
- Various service lines/products supported and delivered
- Prosthesis (Shoulder, Hip, Knee, Foot & Ankle Implants) - Product Sustainability, Quality Engineering
- Forceps, Clamps & Scalpels - Quality Engineering
- ENT devices - M&A integration, CAD & PLM support
- Orthopedic Implants & Spine Instruments - Risk Management, CAD Support
- Wound Closure Devices - Engineering & Design Support
- ECG, MRI, Patient Mobility System & Disinfection System - Engineering & Design Support
Senior Technical Lead
HCL Technologies
Chennai
01.2019 - 01.2022
- Handled design verification & validation testing process for active implantable medical device (Class III)
- Product: Cochlear Implant System
- Developed various test fixtures for pre-compliance testing in accordance with active implantable medical device standard - ISO 14708-1
- Automated Electrode Lead Flex Testing Machine, RF Coil Flex and U-Bend Testing Fixture, Electrode Tensile Elongation Test Fixture, RF Cable Test Fixture (Bite, Tug, Pull and Flex), Electrode Connectivity Test Fixture
- Authored verification plan, protocols and test fixture validation protocols for testing
- Interacted with internal/external testing labs for planning product testing
Technical Lead
HCL Technologies
Chennai
01.2015 - 01.2019
- Handled Production Risk Management and Design Clinical Risk Management projects
- Products: Orthopedic Implantable Plates, Screws, Nails & Wires, Surgical Instruments
- Generated process capability reports using Minitab as part of process validation activities in orthopedic manufacturing
- Supported on IQ, OQ, PQ protocol preparation
- Product: Distraction Osteogenesis Ring System
Design Manager
M/s Appasamy Associates
Chennai
01.2007 - 01.2015
- Defined and developed product requirements based on user, standard and regulatory requirements
- Products: Ophthalmic Surgical Microscope, Video Beam-Splitter C-Mount Camera, Assistant Monocular and Binocular Viewing System, Vitro-Retinal Viewing System, Retinal Camera
- Contributed to technical documentation for product compliance and certification
- Contributed efforts in product verification, validation and post market surveillance activities
Production Manager
M/s Appasamy Associates
Chennai
01.2004 - 01.2007
- Increased production of microscopes by overall 18% by solving key issues in the assembly and standardized its components
- Developed video guided alignment tool for reducing manual errors in Opto-Mechanical System assembly
- Introduced sub-assembly stage inspection process to cut short rework time in final assembly
- Identified and developed new suppliers to cater optical, electrical and mechanical system components
Production Engineer Trainee
M/s Appasamy Associates
Chennai
01.2002 - 01.2004
- Created SOPs for sub-assemblies and assemblies
- Identified and developed jigs and fixtures for easy and consistent assemblies
- Supported and assembled pilot lot production to ensure design acceptance
Graduate Engineer Trainee
Automotive Ancillary Services Pvt. Ltd.
Chennai
01.2001 - 01.2002
- Planned and executed timely inspection of receiving components without disruptions in assembly line
- Generated SPC quality trend reports for incoming components, reported to suppliers for corrective and preventive action, resulting in continuous quality improvement
- Contributed efforts in Gage R&R study as part of Measurement System Analysis
Education
Bachelor of Mechanical Engineering -
Thangavelu College of Engineering
04.2001
Skills
- Autodesk Inventor Professional
- SolidWorks
- Creo
- GD&T
- DFM
- DFMEA
- PFMEA
- Zemax
- Tracepro
- Winlens3D
- Opto-mechanical system design
- Optical alignment tools
- Optical manufacturing
- Inspection test methods
- Minitab Tool
- MDD 93/42/EEC
- AIMDD 90/385/EEC
- EU MDR 2017/745
- IEC 60601-1
- IEC 60068
- US FDA 21 CFR Part 820
- ISO 13485
- ISO 14971
- Internal auditing
- ISO 19011
Certification
- Combined IA Training for ISO 13486:2016 & EU MDR 2017/745.
- Project Management Fundamentals – Coursera.
- Requirements Engineering – Coursera.
Patents
- Illumination System for Ophthalmic Microscope and its Operation Method (US20140092362A1).
Timeline
Technical Manager
Actalent – Allegis Services (India) Pvt. Ltd
01.2022 - Current
Senior Technical Lead
HCL Technologies
01.2019 - 01.2022
Technical Lead
HCL Technologies
01.2015 - 01.2019
Design Manager
M/s Appasamy Associates
01.2007 - 01.2015
Production Manager
M/s Appasamy Associates
01.2004 - 01.2007
Production Engineer Trainee
M/s Appasamy Associates
01.2002 - 01.2004
Graduate Engineer Trainee
Automotive Ancillary Services Pvt. Ltd.
01.2001 - 01.2002
- Combined IA Training for ISO 13486:2016 & EU MDR 2017/745.
- Project Management Fundamentals – Coursera.
- Requirements Engineering – Coursera.
Bachelor of Mechanical Engineering -
Thangavelu College of Engineering
Similar Profiles
TAMILALAGAN M KTAMILALAGAN M K
Senior Executive - HR Operations at Actalent Services - Allegis services India Pvt ltd.Senior Executive - HR Operations at Actalent Services - Allegis services India Pvt ltd.
Supriya SahukarSupriya Sahukar
Senior Software Engineer at Actalent Services (Allegis-Group)Senior Software Engineer at Actalent Services (Allegis-Group)
Prashantha K NPrashantha K N
Design Engineer at Actalent Services (Allegis Group)Design Engineer at Actalent Services (Allegis Group)