• Led the multicultural R & D team on Solis Ambulatory Infusion pump restricted substance compliance upgrade project ($800,000) to complete by the deadline and under budget.
• Directed the multicultural R & D team on Legacy Ambulatory Infusion pump restricted substance compliance upgrade project ($1,200,000) to complete by the deadline and under budget.
• Directed the multicultural R & D team on time Medfusion Hospital Syringe Infusion restricted substance compliance upgrade project ($1,500,000) to complete by the deadline and under budget.
• Led an embedded software test team on a new Syringe Infusion pump for market release. Our diligent team tested the software using iterative SDLC. Result: After 2 years in the field no issues were reported.
• Created a new C++ test system application that cut device test time by 80%.
• Created a 90% complete test application using my Learner and Maximizer Strength from Strength Finder before completing formal training. Result: The application was released on time.
• Led/Tested offshore two-way handheld radio design team. Result: It outperformed the market leader Motorola’s equivalent product.
• Performed all the required regulatory RF testing and wrote a report for the FCC for Type Acceptance for the new handheld two-way radios. Result: FCC approved product to sell.
• Used my Strength Finder strength of Learner and Maximizer. Learned new programming techniques cutting system test time. Result: Approximately $1,000,000 in test cost savings.
• Led a Six Sigma Problem team where we eliminated a product design issue that plagued manufacturing since the start of building the new low-cost handheld two-radio.

Team Member, CAPA Remediation Project   

• Led and Designed Analytical Lab Equipment Validation following Equipment Qualification Process SOP based on ISO13485, ISO14971 and 21 CFR Part 11, 820.
• Led and Designed Analytical Lab Test Method Gage R & R study with Minitab.
• Led and Designed Analytical Lab process improvement for Analytical Lab test specimen preparation.
• Designed an experiment to display variation in a lap shear test for medical adhesive. Result: The test specimen preparation variation was unacceptable. We moved to eliminate the test and accept the adhesive on cert from the vendor thus eliminating the costly test.

Team Member, FDA Class III Medical Device Software Upgrade

• Performed embedded firmware black box testing which identified software issues that had gone undetected internally before. The issues were put on the client CAPA system to track and close out for FDA warning letter.
• Improved black box test procedures to improve clarity to shorten time to execute them by at least 10%% while following company Standard Operating Procedures based on ISO62304, ISO14971 and 21 CFR Part 11, 820.
• Transformed a fully manual error-prone test to use automation to mistake-proof the test and cut test time by 10%.

A matrix environment medical device company managing multiple programs in parallel to protect 7 figure revenue stream using the Waterfall Method. And, transform designs for compliance with Restricted Hazardous Substances (ROHS) European Union standard to be enforced 7/22/2014.

Successfully took over the lead of 5 business critical programs following company Standard Operating Procedures based on ISO13485, ISO62304, ISO14971, IEC 60601 and 21 CFR Part 11, 820 for our FDA Class II Medical Devices. The 5 program budgets totaled $4.4 million.  The teams led had 55 members. The makeup of the teams was Principal and Senior Electrical Engineers; Principal and Senior Mechanical engineers; Principal and Senior Software Engineers; Manufacturing engineers; Electrical and Mechanical Technicians; technical writers; Regulatory staff members; Supply Chain staff members.

• Influenced Environmental Engineering and collaborated with to define an SOP that the engineering teams need to follow to transform products to be restricted hazardous substances compliant that did not exist when I took over leading the programs.
• Identified process training deficiency for new to Smiths Medical program team engineers and scheduled them to complete the training so the work that the Supply Chain staff needed was done correctly.
• Led the team to complete the started Work Break Down structure following the guidelines in the PMBOK.
• Created the MS Project schedule based on the work packets in the Work Break Down Structure.
• Worked with the team to create 3 point estimates for the work packets on the schedule.
• Performed Risk Management using the processes defined in Rita Mulcahy’s book on Risk Management.
• Assigned project work packets to the appropriate program team member in St Paul or India for execution.
• Managed project scope through scope change request forms that required the requester to get estimates of how long it would take to implement the change and an estimate of the cost to make the change.
• Tracked program progress using MS Project and SharePoint with team efforts.
• Created and presented Power Point presentations for program progress to Director Level Stakeholders monthly status meetings.
• Created and presented Power Point presentations for program progress to the President and his Senior staff quarterly status meetings.

Programs Results: Each of the 5 concurrent programs completed by the deadline and each program completed under its budget. No interruption in revenue from product sales for OUS because the products were compliant by the regulation enforcement date deadline.

Converted to employee from consultant.                                                

Following company Standard Operating Procedures based on ISO13485, ISO62304, ISO14971, and 21 CFR Part 11, 820 for our FDA Class II Medical Devices:

• Updated Company SOP’s for improvements covering Software Test and approved.
• Co-developed Traceability Matrix and Software Requirements with the software project engineer and software engineering manager: Result: Software Requirements written so they were testable and Trace Matrix both were approved.
• Authored Software Test Plan, Test Data, Validation Report and peer reviewed: Result: I co-approved with software project and Design Assurance engineer per standard operating procedure.
• Co-developed with delegated responsibility with my test team engineers the black and white box software test and design protocols and peer-reviewed. Result: I approved test protocols in conjunction with Design Assurance per standard operating procedure.
• Developed Project Plan and MS project schedule and managed a team of 17 software test engineers and technicians following iterative/rapid SDLC to write test validation protocols for embedded software and perform formal validation for deliver the report on time for 11/25/2009 FDA 510k submission milestone for U.S. new product launch and new product launch in Canada for first installation on 12/7/2010
• Co-led a PMP study group for a team of program management staff resulting in two staff members taking the PMP exam

A matrix environment medical device company.                                                                                  5/2008 – 4/2009

Following company Standard Operating Procedures based on ISO13485, ISO62304, ISO14971, and 21 CFR Part 11, 820 for our FDA Class II Medical Devices:

• Influenced the Director of the Project Management Office (Smiths-Medical headquarters, Rockland, MA) to bring in a speaker from the Project Management Institute Minnesota Chapter to Smiths-Medical St. Paul to introduce the senior management staff and project leads to Project Management.
• Successfully led a team of team of test engineers and technicians following iterative SDLC to develop a comprehensive set of black box, white box tests, execute and write the validation report for next firmware feature release for the Medfusion 3500 infusion syringe infusion pump. Testing/report completed on schedule.

• Managed a team of 2 Program Managers and 8 Project Managers for 6 Community Outreach Projects.
• Managed the $42,000 Community Outreach Budget. Result Community Outreach Division projects stayed within their budgets.
• Recruited 2 volunteer Project Managers to plan and launch remote from the St Paul Headquarters Dinner/Training meetings for project managers. Result Monthly Dinner/Training Meetings launched in Duluth and Fargo Moorhead area that continue today.

Converted from Consultant to employee for Manufacturing Test.

As a broad skilled Principal Engineer leader, I can be called upon to solve a variety of quality issues, lead teams of engineers, reduce cost and complete individual deliverables. The key tool we used for Quality System documents is Windchill.

Following company Standard Operating Procedures based on ISO13485, ISO62304, ISO14971, and 21 CFR Part 11, 820 for our FDA Class III Medical Devices:

① Supplier Quality Engineering
I was selected for special assignments out of a team of 110 test group members to assist supplier quality engineering utilizing analytical/statistics and test engineering skills.

• Vendor implemented my test process recommendations to improve quality.
• UK plant implanted locked the controls as recommended to prevent errors.
• Mentored the vendor’s test engineer to solve issues on replacement test cell.

② Modules, and RF Test Engineering

• Test application development on Unix platform following medical device SDLC was 90% complete before getting LTX training for an analog-digital module. Result: the Completed application was on schedule.
• Completed FMEA for U.S. submission to the FDA. Result: Completed ahead of schedule.
• Implemented effective CAPA corrective actions. Result: CAPA’s completed on time and closed.
• Released Test Software for RF communication enabled defibrillators with a team of 3 test engineers I led. Result: Released on schedule.
• Test time improvement for high voltage output modules using a unique fixture design and coding the test application in C++. Result: Cut test time by 80%.
• Led a project to release a 3M20 Test application on time utilizing a team of 5 test engineers, mechanical engineer, and electronic technician using best practice project management methodologies. Result:  Test Application released meeting quality goals within the expected time.
• Performed Unix Application white box validation on multiple projects. Results: Completed on time with the written validation report.

Guidant Corporation, Sr Test Engineer Consultant - St. Paul, MN

• Led a cross-functional tean to develop a mixed signal test application that ran LTX AC Synchromaster to test a dual leadless chip carrier used in implantable cardio-defibrillator. Result: Screen with 95% test coverage completed one month ahead of schedule.
• Led a cross-functional tean to develop a mixed signal test application that ran LTX AC Synchromaster to test the high voltage output module for the next generation cardio-defibrillator. Result: Screen with 90% test coverage ready for first proto build.

Directed engineering technician on testing on RF transceiver product and submitted reports to the FCC for Type Acceptance. Result: FCC approval of 10 new models opening the door to increased sales.

Boston Scientific Spot Award – Certificate of Appreciation for going beyond expected four times.
City of Aspen – Certificate of Appreciation for creating multi-year volunteer projects set up for a city park, 2002.
City of Aspen – Distinguished Service Award for planning, execution multi-year volunteer projects for a city park, 2008.
Smiths Medical – Over & Above award January 2011
Smiths Medical – Global Leadership Forum Award 2014