Rory A. Carrillo Email & Phone Number

San Francisco, California, Us

Consulting for various medical device and health-tech companies. We provide the following services for companies to help take their product from concept to commercialization:Marketing:- Market research and strategy- Growth marketing i.e. email marketing, lead generation, branding, advertisement, SEO etc.- Ads & Promo regulations training and content review- Social Media Policy creationProduct Development, Quality & Regulatory- Design and engineering services: mechanical, electrical, software, firmware- Quality System Implementation per FDA QSR and ISO 13485- Regulatory Strategy, Submissions, and Applications for any market (Pre-Submission, 510k, De Novo, Establishment Registration, CE mark, ITA [Canada] etc...)- Technical Feasibility Assessments- Usability study planning and implementation- Clinical study planning and implementation- Clinical Evaluation Reports (MEDDEV 2.7/1 Rev 4)- Technical File Creation- US FDA Agent services- IEC 60601-1 Safety assessments and guidance- Biocompatibility assessment and guidance- Cybersecurity standards and regulations- Verification and Validation strategy, planning, implementation, and execution

Mississauga, Ontario, Ca

- Responsible for the entire development of a novel medical imaging system based on Optical Coherence Tomography (OCT) that will aid surgeons with intra-operative margin assessment during Breast Conserving Surgeries.- Lead and performed product definition activities such as Customer Interviews, User Requirements definition, Use Case Workflows, Risk Assessment, Hazard Analysis, Product Requirements definition, System Architecture definition, detailed device workflow diagrams and descriptions, and requirements analysis and management. - Lead a team of hardware and software engineers - who had no previous medical device experience - to define, design, and develop several clinical prototypes that were used in clinical experiments to understand product feasibility.- Performed system level characterization, designed and developed several system design verification and validation activities for clinical prototype systems and was responsible for several clinical systems successfully passing CSA SPE-1000 Safety Field Inspections- Responsible for creating and developing Design and Use FMEAs and collaborating with cross-functional team members (HW & SW) to ensure all aspects of the device design and use were being considered. - Managed 3rd party development partners.- Responsible for ensuring the product was in compliance to both Canadian and U.S. quality regulations focusing mainly on compliance with 21 CFR 820. - Responsible for complete product requirements and change control management.- Responsible for assessing and ensuring the product would be in compliance to IEC 60601-1 2nd and 3rd edition. - Collaborated with the Quality department to ensure the company was not only developing an quality infrastructure that complies to CSA and FDA guidelines.

Marlborough, Ma, Us

- Collaborate with Marketing and other business stakeholders to develop and implement Market Specifications, Use Case Flow charts, Product Specifications, Design Functional Specifications, Design Verification Plans and Protocols for several system and sub-system level electro-mechanical medical devices. - Develop system-level benchmark testing to measure performance differences between Intravascular Ultrasound systems and custom PCs. - Design and Development of PCBA electrical constraints and layout guidelines- Maintain responsibility for managing and directing several co-development partners for the design of several PCBAs and sub-system level devices. - Provide technical support for Field Service issues and local Complaint Investigation Services ranging from troubleshooting hardware failures to debugging undetected virus issues. - Design, develop, and assess the feasibility of new technological solutions for next-generation IVUS systems. - Design, Implement and Manage a Requirements Management System using Rationale RequisitePro.- Interacted with Physicians to identify needs and problems and converted these needs into product concepts and functioning prototypes. - Developed and Performed several animal studies to assess feature enhancements and/or functioning prototypes.

Marlborough, Ma, Us

- Perform research and development for Image Improvement on iLabTM Ultrasound Imaging System- Design in-vitro test methods and models for the development of a new IVUS real-time imaging algorithm to improve lumenborder detection.- Design tissue mimicking phantoms to create a benchmark for the performance of IVUS systems.- Gather and analyze data to benchmark and compare the performance of multiple products using specifications or empirical test data.

Marlborough, Ma, Us

- Performed equipment installation, operation, and performance qualifications. - Performed production support activities. Monitored process and equipment performance. - Identified and implemented process improvement activities to increase yield, efficiency, and throughput. - Developed specifications for a production process and equipment.- Trained product builders, quality control, and technicians as necessary, on equipment and documentation.- Responsible for Non-Conformance Reports (NCR), and participated in CAPA investigation and analysis. - Six Sigma Certification (Yellow Belt)

Performed equipment installation, operation, and performance qualifications. Performed production support activities. Monitored process and equipment performance. Identified and implemented process improvement activities to increase yield, efficiency, and throughput. Developed specifications for a production process and equipment. Trained product builders, quality control, and technicians as necessary, on equipment and documentation. Responsible for Non-Conformance Reports (NCR), and participated in CAPA investigation and analysis. Six Sigma Certification (Yellow Belt); Created instructions manual for natural gas analyzers which total $13 million annually in revenue. Designed, using AutoCAD, and hand-built prototypes of gas analyzers for research and development. Updated and reorganized a database of gas analyzer schematics via AutoCAD.

Los Angeles, Us

Installed and troubleshoot software and PLC modules to increase and optimize the efficiency of the UV lamps - Resulted in an annual savings of $13,000. Designed and implemented an overheat protection circuit that was independent of the control circuitry. Performed environmental testing. Designed and implemented an on-line network that collects production information from 22 production lines. The network utilized a SQL server, an Access database, and Visual Basic Programming. Conducted an analysis on the U.V. performance of the DVD production lines. The analysis led to a more robust process, increasing the lifetime of a UV lamp, thus creating a cost initiative. Annual savings – over $50,000 a year.

Orlando, Fl, Us

Processed and analyzed nano-effects of a ceramic reinforced aluminum composite with Hot Isostatic Press, Cold Press, and High Energy Ball Mill. Utilized Scanning Electron Microscope to understand the structure of the nano-sized composites. Conducted X-Ray diffraction techniques to further understand the crystallization behavior of the ceramic reinforced composite

Bachelor Of Science, Electrical Engineering; Digital Signal Processing Specialty

Master Of Science, General Engineering; Biomedical Engineering

Ba, Pre-Engineering