Ramprabhu Ramasamy

Professional Summary

Dynamic and results-driven leader with 24 years of extensive experience in R&D Leadership, Product Management, and Software Engineering for regulated embedded systems and dispensing platforms.

Proven domain-and technology-agnostic strategic visioner with a track record of driving innovation, managing cross-functional, onsite-offshore teams, and delivering complex software solutions.

Expert in regulatory compliance, including 510(k) Submissions, IEC 62304, and ISO 14971 for medical device software development.

IEC 62304 ISO 14971 510(k) SaaS Embedded Systems

Education

Bachelor of Engineering Computer Science (2002)

San Diego, CA

ramprabhur@gmail.com

Innovation & Impact Highlights

$300M Value Proposition

Awaiting Patent Filing

Alarm Silencing

Improved nurse workflow efficiency by an estimated 18% and reduced non-actionable alarms by ~22%; recognized as a $300M value proposition at the BD Innovation Summit.

SaaS Solution

Smart Infusion Dashboard

Enabled real-time analytics that reduced troubleshooting time by 30% and projected to increase fleet utilization by 12%.

FDA 510(k)

Hospital Information Systems Integration

Cut internal verification cycle time by 25% and accelerated 510(k) submission readiness.

Process Innovation

Software Trace Analysis

Reduced traceability gap-closure time by 40% and improved audit readiness scoring across teams.

Professional Experience

Becton Dickinson (BD)

2006 – Present

Current Role

R&D Leader – Released Software Product Management

Lead end‑to‑end lifecycle management for released software, ensuring full IEC 62304 and ISO 14971 compliance.
Direct and influence a 70+ member cross‑functional organization across engineering, quality, regulatory, and product teams.
Own product strategy and roadmaps, driving prioritization, backlog management, and high‑quality sustaining releases.
Deliver cost‑optimization initiatives targeting 50% reduction in sustaining release expenses through automation and process improvements.
Champion customer, market, and field insights to guide roadmap decisions and product enhancements.
Supported successful regulatory submissions, including 510(k) for critical software components.

Associate Director, R&D – Software Engineering (Embedded Systems)

Handled teams with an overall budget of $14M.
Oversaw robust embedded software development for mission-critical systems, maintaining IEC 62304 compliance.
Implemented rigorous risk management processes per ISO 14971.
Collaborated with regulatory teams, providing essential 510(k) documentation.
Drove innovation by introducing SaaS-based solutions including the Smart Infusion Dashboard and Alarm Silencing feature (awaiting Patent filing).
SaaS initiatives valued at $300M at the BD Innovation Summit.
Innovated Hospital Information Systems integration, enhancing interoperability and compliance.

Senior Manager, Software Engineering – Dispensing Platform

Directed all software engineering efforts for dispensing platform solutions, ensuring adherence to medical device software standards.
Led diverse cross-functional teams in Software Engineering and Verification, managing end-to-end development and testing processes.
Championed process improvements and adopted Agile methodologies, accelerating product delivery with $2.8M cost savings.

Core Completencies

Core

Product & Strategy

Software Product Management Roadmapping End-to-End System-Level Solutions

Engineering

Embedded Systems Development Systems Engineering Test Driven Development

Regulatory & Compliance

IEC 62304 ISO 14971 510(k) Hazard Mitigation & Traceability

Leadership

Cross-Functional Team Leadership Agile & Release Management

Innovation

Innovation & Continuous Improvement SaaS Solutions

I am a R&D Leader