David Lammi Email & Phone Number

Kirkland, Washington, United States

Snoqualmie, Wa

Led the company’s top priority program for the next generation patient monitoring platform. This is a do-or-die program-of-programs for the company. This program consisted of over 200 people within engineering spread out over 5 locations in three countries. This program had five program mangers reporting into myself. It was broken down into acquisition, patient monitor, surveillance, enterprise platform and cloud. Created onshore/offshore teams for each product and assigned Program Managers. Standup budgets, work breakdowns, project plans, develop requirements and schedules. Worked cross functionally across the organization with PMO, engineering, UX, marketing, design verification, design validation, safety, regulatory, quality assurance, manufacturing and executive management. This resulted in delivering the product set to functional prototypes in spite of the Covid disruptions worldwide, securing a future for the company.

Snoqualmie, Wa

Owner of the following three software/hardware projects, Xhibit Central Surveillance (SW/HW), Xhibit Telemetry Receiver (SW/HW) and XprezzNet (SW). Developed product requirements, set scope for the release, drove clarity, priority and set product backlog order. Worked cross functionally with engineering, regulatory, marketing, design verification, design validation, safety and compliance to manage the release of the product into production. Organized and drove change control boards for all incoming issues and scope change requests. Drove risk management and all of the deliverables needed for the release of a medical device. Delivered all projects on time. The Xhibit Central Surveillance release was completed and ship authorized one day prior to the original target date as set from the initial schedule. The Xhibit Telemetry Receiver was inserted in the middle of Xhibit release and I still found a way to ship on time.

Snoqualmie, Wa

As Director, stepped in to drive a struggling software development team to complete a highly desired product set, Xhibit Central Surveillance, Xhibit Telemetry Receiver and XprezzNet. This included ensuring the team was focused and working extra hours for seven months straight while keeping attrition to a minimum. Directed the daily management of the software development staff; owned functional management of the software development lifecycle; owned resource allocations and ensuring appropriate skill sets for the staffing of projects. Worked to impress upon the developers the importance of SOLID design principles and the benefits of interfaces. Brought in a Microsoft subject matter expert to conduct a unit testing course and teach the importance of interfaces in creating unit testable code. Also drove the implementation and use of static code analysis across new code development and the implementation of unit tests for all new and refactored code. Setup a new architectural group to drive architecture and major design decisions. Fostered a culture with the development staff to embrace code reviews and the value of getting peer reviews from multiple sources. Owned and implemented new R&D work instructions for Software Versioning and Software as a Medical Device Unique Device Identifier (SaMD UDI) compliance and generated IEC 62304 compliant software development plans for numerous projects. Participated in FDA and third-party inspections as a subject matter expert directly with the inspectors. Code quality rose and our releases improved.

Issaquah, Wa

As Director of Design Services, owned management of the Software Design Verification, Technical Publications, Software Tools Development and Software Build groups. Led the charge to convert publications to Simplified Technical English (STE) to reduce overall translation costs. This led to the implementation of Acrolinx and our own Spacelabs grammar dictionary (A modified set of STE for our space). The goal was to reduce translation costs by being able to take advantage of translation memory. Led companywide team events to motivate a company to accomplish a mission and collect their feedback. Followed a modified World Café method - http://www.theworldcafe.com/. Owned the coordination of and planning of moving R&D from Issaquah to Spacelabs’ new location in Snoqualmie, WA. This included setting the vision for and executing the design and implementation of a $1 million plus new engineering test lab with advanced networking capabilities. This lab is often a tour destination for not only Spacelabs clients but also field and sales staff. Drove and owned high profile incidents to resolution for FDA 483 and Warning Letter remediation work, ensuring compliance. Generated several key design control work instructions, for topics such as design traceability and design verification. Managed resources in a matrix organization to assure key projects were staffed based on priority, urgency & skill set.

Issaquah, Wa

Led the Software Design Verification team. Built and coached teams of software testers in a highly regulated development environment. This included a local team in the USA and off-shore teams in India and China. Owned the management of the R&D IT staff and the software maintenance budgets for licensing across all of R&D. Owned the design verification process for compliance with FDA CFR 820.30 Design Controls and oversaw/created design verification plans, requirements, design verification protocols and test reports for all Patient Monitoring and Connectivity products with software. Led a companywide team events to motivate a company to accomplish a mission and collect their feedback. Followed a modified World Café method - http://www.theworldcafe.com/. Managed resources in a matrix organization to assure key projects were staffed based on priority, urgency & skill set. During this time, I was honored to be part of a special leadership training course provided by Spacelabs. This course was only offered to a few key individuals’ company wide.

Issaquah, Wa

Led the development of software design verification plans, protocols and reports for Spacelabs Healthcare’s patient monitoring products and enterprise software. While in this role, I was able to build the Design Verification team locally and owned the development and creation of an off-shore design verification team in Hyderabad, India. This team started slowly and grew over time. Also drove a successful in-house test case management and reporting system throughout R&D. Oversaw the revamp of the UI to a web-based Silverlight application with development in Hyderabad, India. This tool was actively in use at multiple R&D sites. It successfully promoted test case reuse and sped up the time to verify releases.

Issaquah, Wa

Owned and created test plans, protocols and reports for Spacelabs Intesys Clinical Suite (ICS) software. Drove changes to Design Verification processes as a response to an FDA 483 observation in 2006. Architected, designed and implemented a test case management and reporting system. Adopted by other Spacelabs R&D sites including our class III anesthesia division. Software Test Engineer for multiple releases of the company’s enterprise software suite, ICS.

Windows CE Tools Group• Development of automation used to test Microsoft Platform Build for Windows CE 5.0 (Macallan Release)• Owned automation for install/uninstall and SDK target release features.• Ensure execution of automation and the collection of results.• Report and track bugs, and verify bug fixes.

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