John Grottodden

Project: FDA-Compliant Software Development for Medical Device

• Oversaw the commercialization of product software, directing a redesign effort including robust error handling and risk controls, achieving an 80% cost reduction compared to the vendor-developed prototype
• Monitored team performance and managed work items, defect tracking, and configuration using Jira and Bitbucket, ensuring project milestones were met on time and within budget
• Define project scope, identify risks, allocate resources, and provide subject matter expertise based on established project management techniques
• Make presentations to management on project updates, project cycle, and expected results - Ensure projects are completed on time and within scope
• Spearheaded the implementation of automated testing frameworks, enabling the team to efficiently validate software behaviors using preconditions, event simulations, and verification scripts

Project: Cybersecurity FDA Pre-Submission

• Assured timely product approval and release for a cardiac mapping system by following FDA guidance and managing a global team for the creation of a cyber-security FDA pre-submission application
• Created a plan, assigned tasks and worked closely with contributors to generate the required deliverables:
• Manage vendor and service providers to define project scope and performance expectations

Project: IT Infrastructure Refresh

• Re-hosted all web services and applications to new server environments
• Managed the full project lifecycle, including scope, schedule, cost, risk, and procurement
• Conducted change management, including stakeholder analysis and execution of mitigation plans
• Documented architectures, implemented security controls
• Project: Cybersecurity Program Installation
• Implemented an Information Security Program aligned with NIST framework, passing SEC/FINRA audit
• Developed policies, processes, and artifacts to ensure regulatory compliance
• Performed threat analyses against SANS top20 risks, planned and executed mitigation projects
• Directed release of IT policies, change requests, and document control procedures
• Project: KonnexME CRM Application Development and Integration
• Enhanced business partner engagement by delivering a secure, feature-rich CRM
• Simplified workflows by integrating three systems
• Developed project roadmaps and governance processes, aligning technology with business needs

Project: CRM Patient Data Systems

• Led architectural initiatives while delivering new features to a web-based healthcare data system
• Developed an architecture roadmap, integrating key system improvements
• Coordinated execution with business, marketing, engineering, QA, and regulatory teams
• Reduced required staff from200 to40 by improving poorly designed components over four release cycles
• Quality Program Manager (Consultant)
• Project: Insulin Pump Software
• Conducted software process assessment following an FDA recall
• Managed projects to realign software development processes to standards

Project: GPS-Aided Inertial Navigation Systems

• Delivered a GPS-aided inertial navigation system for Raytheon’s SDB II program
• Managed development and delivery of embedded software, hardware integration, and simulation tools
• Coordinated work activities, aligning milestones with the customer’s master schedule
• Led change control processes to resolve issues and implement fixes