Mike O'Brien Email & Phone Number

Cambridge, Ma, Us

Cambridge, Ma, Us

Boston, Massachusetts, United States

Boston, Massachusetts, United States

- Project Manager for the majority of the company's goals, large and small including, event planning, major international purchases, merchandise, and art development. - Conduct independent research using the various historical translated texts- Teach 3 times per week as a head fencing instructor in the school- Manage the company's social media accounts as the community manager

▪ Managed 10 different medical device projects using Agile and Waterfall methodologies▪ Acted as project manager for teams as small as 3 and as large as 10 engineers▪ Used Microsoft Project to plan and track timelines and objectives▪ Worked with engineers and uppermanage to resolve scheduling and resource conflicts

- Managed the phase 1 launch of a 2 million dollar medical device project consisting of six different contract manufacturing companies using a combination of Agile and Waterfall style timelines- Managed Phases 1,2, and the decommissioning of a 1 million dollar medical device project - Reported the actual spend vs expected budget of the projects on a weekly basis- Approved and tracked all incoming purchase orders related to projects

Burlington, Massachusetts, United States

- Acted as Project Manager for manufacturing line process improvements. - Investigated multiple non-conformance reports and created and executed suitable CAPAs generated by weekly complaint log- Conducted regular internal audits for quality processes- Conducted regular external supplier audits- Assisted with preparation for and execution of back room activities for external auditors- Wrote and updated multiple manufacturing work instructions and quality processes- Executed Preventative Maintenance procedures on equipment

Boston, Massachusetts, United States

- Executed Verification and Validation on various pieces of equipment (IQ,OQ,PQ)- Created Preventive Maintenance system for equipment and procedures- Created a calibration tracking and monitoring system for equipment- Wrote and updated multiple manufacturing work instructions and quality processes

Greater Boston Area

- Acted as Project Manager for new assembly line creation and operator training program- Assisted in the FDA approval and launch of the CorPath GRX Robotic System- Worked with new product development team to complete three special 510(k) projects and transfer them to Manufacturing- Participated in development, validation, implementation, and training for ARENA electronic database management system- Investigated multiple non-conformance reports and created and executed suitable CAPAs- Wrote and updated multiple manufacturing work instructions and quality processes- Conducted team trainings on GDP, new work instructions, quality processes, and use of electronic database systems- Conducted regular internal audits for quality processes- Assisted with preparation for and execution of back room activities for external auditors- Maintained Preventative Maintenance log and tracking

Raynham, Ma

- Generated change orders, master verification/validation plans, and special work orders for validations, manufacturing procedures, and test methods. - Updated tooling drawings, using AutoCAD, for process improvement, new tool testing, and new tool implementation - Wrote manufacturing procedures, test protocols, change orders, and validation reports for new microsensor test equipment- Conducted Gauge R&R training and executed GRR testing for the qualification of test methods to be used in product improvement verification / validation- Major Impact: Acted as primary manufacturing engineer for new product implementation of catheter mounted microsensor

Sunnyvale

- Acted as Project Manager for 3 simultaneous Continuous Improvement projects - Acted as Project Manager for 5 simultaneous new product development projects - Investigated multiple non-conformance reports and created and executed suitable CAPAs- Transferred sinus cavity medication delivery device from R&D to manufacturing- Conducted IQ/OQ/PQ during new product transfer from R&D to manufacturing- Executed design and process validation and verifications- Acted as Quality representative when meeting with product and material suppliers- Designed custom tools, fixtures, and gauges, using SolidWorks (CAD) for the forming of plastic tips, aiding in the assembly process of devices, and streamlining and standardizing part inspection- Built catheters, introducers, injection molded tips, and full medical device assemblies- Increased production line output from 1,000 parts per month to 2,000 using Lean manufacturing techniques- Awarded Employee of the Month award for February 2015 Major Impact: Increased the dollars per hour productivity of a Top 10 level project by 82% as a member of the Continuous Improvement Team

Menlo Park

Quality Engineer June 2011- April 2012 Reworked existing Non-Conformance Material Report Process Participated in Software Validation for new Internet interfaceWrote new Quality Assurance Standard Operating Procedures Tested and Qualified new Quality Assurance test machines and tools Major Impact: Updated NonConformance Report system and all current Quality Assurance Standard Operating Procedures to be more efficient and use newer test hardware

Participated in the Digital Operating Room testing of the new Camera Control Unit Test DeviceTested new hardware and software for laparoscopic surgical applicationsCreated and implemented new protocol for use of new technology in Operating RoomsProduced instructional program for use of new softwareOperated on a multi-discipline team at the Garfield Innovation Center Major Impact: Project established a protocol and diagnostic for the operation and maintenance of operating room monitors, thereby reducing operating room down time.

Primary Performance Test Engineer for FDA 510(k) application Created new manufacturing processes for new catheter composition materialsDeveloped and Evaluated new testing procedures for new blade design and anti-clog featureDesigned new tools using SolidWorks (CAD) Major Impact: Project resulted in successful FDA 501(k) application for JetStream G3® Atherectomy device.