Robin Jacob Email & Phone Number

Raleigh, Nc, Us

North Carolina, United States

Engineering Project Leader:Leading a customer-focused team in developing medical devices with strong project management skills. Overseeing project setup, maintenance, and cost control, ensuring on-time, budget-compliant delivery and ongoing recognition for leadership excellence.Supply Chain and Vendor Relationship Specialist:Spearheading critical vendor relationships and supporting supply chain development in medical device manufacturing. Proactively selecting vendors, developing key relationships, and playing a pivotal role in initiating material specifications and assembly instructions for efficient product development.Manufacturing Process Development Expert:Optimizing manufacturing processes for medical devices in compliance with ISO 9001 and ISO 13485 standards. Providing essential support in CAD/drafting, tooling/fixturing, and manufacturing line design, emphasizing a "speed to market" approach.Quality Assurance and Compliance Coordinator:Operating in a dynamic environment, ensuring adherence to quality standards and compliance in medical device development. Supporting validation protocol development, initiating DFMA processes, and contributing to risk analysis and compliance with FDA and ISO requirements (21CFR820, ISO 13485) Strengthening quality assurance processes for enhanced departmental efficiency.

Innovative Technology Integration:Led the initiative to transform NC State technology into a wearable diagnostic device designed for ICU use, navigating the complexities of translating academic research into practical medical applications.Regulatory Compliance Efforts: Diligently worked on implementing and managing design controls and design history file documentation, striving for adherence to FDA and ISO standards throughout the product development journey.Stakeholder EngagementDeveloped and maintained strong relationships with clinical stakeholders, hospital administrators, and potential customers, acting as a vital link between technical development and user needs. Conducted comprehensive market research and interviews to gather invaluable insights for product refinement.Design IterationLed iterative design processes to refine the product, continually incorporating feedback from stakeholders and end-users. Maintained a customer-centric approach to product development, adapting to the evolving needs of the healthcare industry.Cross-Functional Collaboration:Collaborated with cross-functional teams, including R&D, manufacturing, quality assurance, and marketing, striving to facilitate a smooth transition from product concept to market launch. Fostered communication and alignment between departments, contributing to the development process.

Conducted successful clinical discovery phase in hospital to identify 25 unmet medical needs, gaining insights into patient and clinician perspectives, validating commercial viability of solutionsDesigned, built and tested prototype for class II pressure injury device focusing on reliability, and ease of use in clinical protocols with improved patient outcomes and increased customer satisfaction Leading cross-functional collaboration with engineers, nurses, and hospital administration in development to improve device functionality and usability Utilizing design control principals, building a DHF including user needs, risk analysis, product specifications, manufacturing and design reviews to ensure FDA and ISO standard compliance We identified a crucial need to address and have successfully designed, built and tested our first functional prototype. We are currently developing a path to market strategy including FDA classification, patent creation and funding recruitment

Ms, Biomedical Engineering: Medtech Innovation & Entrepreneurship

For those interested in acquiring the skills necessary to lead biomedical-related early-stage ventures or to drive new product development.

Post Bacc, Pre-Medical Studies

Bsc, Population Health