Engineering consulting company with a wide range of capabilities specializing in medical device product development, safety assurance cases, systems engineering, remediation, and process improvement.

Systems engineering for new infusion pump products. Consulting on new process initiatives. Risk management, user needs, requirements, and verification.- Lead systems engineer on new infuser product family fully utilizing advanced model-based systems engineering (MBSE using MagicDraw) and product line engineering techniques to enhance the depth of understanding of the entire product family’s capabilities.- Named as inventor on 7 provisional and 1 utility patent applications. Member of innovation review committee charged with prioritizing and shepherding the best innovation ideas toward patent applications.- Temporarily assumed management responsibility for several of Hospira’s Global Device R&D functions: systems engineering, risk management, reliability engineering, requirements engineering, and verification and validation. Reorganized the teams around assigned products to reinforce project priorities.- Rapidly identified, hired, and deployed new contractors to build Hospira's first safety Assurance Cases for Symbiq infusion pump in response to new FDA infusion pump 510(k) guidance. This Assurance Case work also drove the need to completely revamp and remediate the product’s risk management file with full fault trees, system hazard analyses, and lower level FMECAs to assess reliability.- Assumed ownership of System Verification activity for Symbiq infusion pump program in pursuit of company’s first 510(k) under the new FDA Infusion Pump Guidance. Quickly built up a small team to write and execute new testing and regression analyses necessary to complete the activity.

Coordinate chapter recruiting with corporate education of INCOSE mission, objectives, and benefits.

Remediate IVD medical device design history file documents, develop standard operating procedures, and reusable document templates.

Responsible for systems analysis, hazard/risk analysis, systems architecture, requirements management, verification, and validation of Renal medical devices.-- Designed and deployed common requirements management "template" in DOORS covering product level requirements, system requirements, use cases, subsystem requirements, risk analysis, and test engineering across all device engineering groups.-- Taught actor-oriented analysis techniques to more quickly gather user needs, better describe use cases, and innovate within the problem space rather than rehash old solutions.-- Modernized V&V team around actor-oriented testing philosophy. Rearchitected test set for reusability and efficiency. Redesigned roles and responsibilities to better support parallel testing, outsourced testing, and advanced test methods.

Responsible for 50 member dev team and $7M budget. Duties included strategic project prioritization, budget mgmt and forecasting, perf mgmt, proj mgmt, customer support, and leading mentoring sessions.-- Deployed core dev processes to eliminate redundant work and improve resource utilization resulting in an annual 50% productivity gain over 3 years.-- Devised strat for continuously resolving high impact problems resulting in a “Best in KLAS” customer sat rating after only 2 years, held ranking for last 3 years.-- Led project to deploy CMMi-based dev processes. Completed project in 12 months vs. industry average of 30 months.-- To improve customer upgrade rate, deployed automated tools to improve linkage of requirements to dev team work resulting in a 75% reduction in escaped critical defects in first project using new tools.-- In a flat market, created new process to improve strategic relevance of new features increasing sales 30% annually over 3 years.

Planned and directed development projects for surgical management and materials management Windows client/server applications. Responsible for project scope, requirements capture, estimation, tracking, defect resolution, change management, and delivery of product to customers. Hired, trained, and directed staff of 12 software engineers. Led cross-functional project management team.-- Fighting poor organizational accountability, created and trained cross-functional management teams at both the strategic and project levels with clearly define roles, responsibilities, and issue escalation paths resulting in a 50% reduction in Sr. Management issue escalations in less than 1 year in use.

Departmental responsibility for multi-disciplinary engineering team of 80+ software, hardware, and mechanical engineers, testers, and technicians. Duties included strategic planning, capital and resource budgeting and forecasting, continuous engineering and quality process improvements, multi-project resource planning, and personnel management.-- Instituted continuous process improvement program resulting in a 40% improvement in the Malcolm Baldrige Bullet Application after only 1 year in use.-- Collaborated with peers to define and roll-out an internationally integrated systems engineering process resulting in dramatically improved communications, streamlined requirements definition, verification, and validation processes, and enhanced employee satisfaction.-- Worked with senior colleagues to implement strategic review and planning process resulting in focused engineering and manufacturing initiatives that increased profits over 10% annually for 2 years.

Functional responsibility for 40+ member software team. Duties included strategic planning, capital and resource budgeting and forecasting, continuous engineering and quality process improvements, multi-project resource planning, and personnel management. Dual role as project leader for successively larger imaging system projects.-- Led 18 month project to analyze and architect new imaging platform. New architecture consolidated 4 modality-specific imaging systems onto one common hardware/software platform significantly reducing total engineering costs through reusable components and reducing manufacturing costs through higher aggregate production volume.-- Forced to grow software team for the above project, initiated crash hiring program growing software team from 25 to 40 in just over 1 year.-- Initiated multi-pronged 1 year plan that cut turnover rate from 20-30% annually to under 10% for the subsequent 2 years.

Functional responsibility for 8 software engineers. Duties included personnel management with a dual role as project leader for small projects.-- Identified opportunity to provide a low-priced alternative to existing product line. Analyzed market, developed business plan, hired, and led project team to build advanced PC-based review station in 12 months. Increased sales revenue 8-12% during life of product.-- Seeking to improve the hiring rate of software engineers in a tight supply market, created cooperative college intern program with 3 local universities in less than 6 months. This new pipeline of pre-trained and low cost software engineers improved the direct hire rate 15-20% after the first group graduated and for 5 years after that.

Senior Principal Software EngineerPrincipal Software EngineerSenior Software EngineerSoftware Engineer

Responsible for the design and development of mil-spec hardware and software for microcontroller-based aerial cameras.