Hi, I'm

Trijeet Emmanuel Gomes

MEDICAL DEVICES PROJECT MANAGER

Driving Innovation in Biomedical and Regulatory-Compliant Product Development

4+

Years Of Experience

10+

Projects Completed

5

Certifications

My Skill Set

I Provide A Wide Range Of Skills

Regulatory Compliance

Understanding and applying FDA 21 CFR Part 820, ISO 13485, CE marking, and ISO 14971 standards to ensure products meet all legal and safety requirements for global market approvals.

Project Execution

Leading projects using Agile, Jira, Gantt charts, and CAPA systems; managing phase-gate processes to ensure timely delivery, cross-team collaboration, and compliance with engineering workflows.

Product Development

Developing medical devices from concept to transfer using SolidWorks, design controls, DHF/DMR, and validation protocols; optimizing function, quality, and manufacturability at each stage.

Why Choose Me

My Experience Area

Regulatory Compliance
90%
Product Development
70%
CAD & Simulation Tools
50%
Verification & Validation
70%
Project Execution
80%
Technical Documentation
60%
Data Analysis & ERP
60%
Process Optimization
80%

Projects

My Amazing Works

Experience

Level Six Inc.

D2C Customer Service Specialist

January 2025 – Present

Managed 120+ weekly global support queries across multiple channels while maintaining SLA targets. Oversaw 80+ warranty claims and returns using audit protocols. Led inventory forecasting to reduce stock delays by 28%. Coordinated cross-departmental workflows and fulfilled all deliverables, including time-sensitive contracts with public entities.

Koichi Ramen Westboro

Assistant Manager

March 2024 – December 2024

Oversaw daily operations for 200+ customers, integrating HACCP systems to standardize food safety. Achieved 40% revenue growth within 3 months through optimized scheduling and staffing. Promoted in record time due to effective interdepartmental process design and zero-code infractions during inspections.

E-Pro Bot Inc.

Serving Robot Consultant & Technician

November 2023 – February 2024

Deployed robotic systems for 15+ clients and programmed custom navigation logic. Conducted client training for 30+ users and supported B2B presentations. Enabled successful market expansion into Quebec by managing multi-site hardware and software rollouts.

Afrodeeziacs Fast Food Corp.

Chief Operations Officer

July 2023 – December 2023

Directed end-to-end operations, DEI-focused hiring, vendor negotiations, and expansion logistics. Spearheaded site migrations with a 40% efficiency gain. Facilitated HQ expansion through contract wins, onboarding workflows, and KPI-driven performance metrics.

DEGREE

EDUCATION

Bachelor of Technology in Electronics and Communication Engineering

August 2018 – July 2022

RCC Institute of Information Technology, India

Master of Engineering (MEng.) in Biomedical Engineering

September 2022 – June 2024

University of Ottawa, Ontario

Let's Connect

Please fill out the form on this section to contact with me. Or call between 9:00 a.m. and 8:00 p.m. ET, Monday through Friday

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    Developed with love by Trijeet Emmanuel Gomes © 2025