Romer De Los Santos Ii Email & Phone Number

Portland, Or, Us

● Research and develop best practices for the development of medical device software compliant with current US and internationally recognized standards. ● Lead efforts to develop scalable solutions for the management of variants, product line engineering, complex software systems, risk, cybersecurity, and other topics. ● Lead training in the use of Jama connect Software, the development and management of requirements and risk, and other topics related to the development of medical devices.● Manage a mixed portfolio of clients from startups to large multi-national corporations. ● Partner with multi-disciplinary teams to analyze their end-to-end development process and provide advice and guidance as required.

Portland, Or, Us

• Provide guidance to clients on proper compliance with US and internationally recognized standards and best practices.• Provide training in the use of Jama Connect software.• Analyze client workflows and suggest ways to alleviate any roadblocks.• Developed SaMD Framework in Jama Connect to support medical software development activities. • Manage a portfolio of 20+ clients.

San Diego, Ca, Us

• Lead Polarion and Jama synchronization strategy. • Core Team Leader for an automated liquid handling project.• Software Project Lead coordinating development effort for an end to end clinical assay workflow dependent on 6 active projects.• Requirement management for clinical assay, laboratory automation, and microarray projects.• Coordinate and participate in risk management activities.• Facilitate product increment and release planning.• Work with remotely located teams in the US, UK, and Singapore.

San Diego, Ca, Us

• Rework legacy RUO knowledgebase requirements to IVD.• Coordinated efforts of three software systems engineers on a cloud-based case management, interpretation, and reporting software.• Developed C# risk management tool that automatically generates a Use Risk Assessment and Software Failure Modes and Effects Analysis from Jama.• Elicit, analyze, and develop requirements for NIPT (Non-Invasive Pre-Natal Test), RUDG (Rare and Undiagnosed Genetic Disease), lab automation, variant interpretation, and cloud-based projects.• Project management using Agile (Scrum) Development Methodology; certified scrum master and product owner.• Improved Scrum processes and developed actionable sprint analytics. • Provide mentoring and training in Scrum, Jira, Jama, UML activity, sequence, and context diagrams, requirements elicitation and management, and software risk assessment.• Work with remotely located teams in the US, UK, and Singapore.

San Diego, Ca, Us

• Released clinical sequencer through FDA.• Generate and maintain software documentation in a regulated environment for the US, EU, and China. • Partnered with Software Quality Assurance to improve risk manage processes.• Revised requirements development and management best practices, and software requirements template. • Created online training materials and provided training for Jama and systems analysis. • Developed paperless record keeping for manufacturing with electronic signature support. • Managed training programs for sequencing platforms. • Worked closely with remotely located Scrum teams in the US, Singapore, and India.

Suwanee, Georgia, Us

• Led 4 internal ISO audits of manufacturing, shipping and receiving, facilities departments, and the customer improvement process. • Implemented Agile best practices appropriate for the medical device industry. Participated in SCRUM meetings every other day with a 2 week sprint cycle.• Helped develop the breast imaging accessory and created an image viewer specific for breast images. • Created a synchronized dual screen touchable user interface for a surgical gamma camera using WPF.• Revised the Standard Operating Procedure for Software Quality Assurance.• Created and presented training programs for DICOM, Requisite Pro (requirement tracking), JIRA (defect tracking), software quality assurance, and technical overviews of Digirad’s product line for customer service and engineering.• Created custom defect tracking workflow as the JIRA administrator.

Suwanee, Georgia, Us

• Reduced the cost of the Cardius Gamma Camera by at least 40% by replacing mechanical controls with a software interface. • Converted and documented algorithms from the physicists’ experimental programs in IDL and VB6 to C#.• Documented and placed 11 separate firmware units under design control.• Created workflow diagrams for 4 gantry configurations by examining legacy firmware.• Catalogued over 9 software configurations for gamma cameras in the field and created a software compatibility matrix to aid in customer service issues.• Developed a patient data management system with a C# user interface and a SQL Server 2008 backend.• Developed and maintained firmware for detector heads and gantry controls, and software tools for data acquisition and image processing.• Streamlined the manufacturing process by condensing complex multi-step electronic module calibration to a simple button press, saving the technician 2 hours of labor every run.

San Diego, California, Us

• Developed software application to download data from glucose sensors for clinical trials. • Provided technical support for ongoing clinical trials. • Developed software applications for manufacturing.• Developed online data analysis tools using ASP.NET.

Minneapolis, Mn, Us

• Developed and maintained firmware for insulin infusion pumps.• Developed and maintained software application to download, track, and analyze data from insulin infusion pumps, glucose meters, and glucose sensors.• Developed and maintained software for manufacturing and engineering tools.• Managed a software verification and validation team of 9.• Managed a firmware development team of 3.