Engineer Project Manager
Resume:
David Crossland
*********.*****@*****.***
Eight years leading projects, writing, and executing protocols for Class 2 and 3 medical devices On-site at customer, in house Asia, and state side operations introducing and transferring knowledge and processes.
Terumo Ann Arbor, MI Jan 2012 – present System Test Engineer (Consultant)
• Designing, critiquing, and executing validation efforts for proprietary Data Management System for a heart lung device with the product development team
• Dry run sub system level functionality in conjunction with consent decree
St Jude Medical Plano, TX Sept 2011 – Jan 2012 System Test Engineer (Consultant)
• As part of a remediation effort examine requirements and protocol documents previously written and executed to assure accuracy (Deep Brain Stimulus)
• Rewrite requirements using problem solving to enhance and or improve validation.
• Develop engineering lab testing protocols against rf medical device specifications.
• Provide engineering level research on qualifications, verifications, and validations protocols and reports for accuracy.
Orthofix Lewisville, TX Sept 2010 – Sept 2011 Quality Engineer (Consultant)
• Write protocol to certify product reliability for new 510K submission coinciding with new plant certification for (bone growth promotion device).
• Complaint investigation, failure analysis, and MRB to improve product turn time from one month down to one week leading team of engineers and technicians.
• Develop engineering lab testing for environment stressing protocols for Lithium battery packs based on device specifications and MTS (mechanical test systems) reliability environment prior to product launch for tension and compression testing.
Benchmark Electronics 2009- 2010 Customer Medtronic’s
• Participated in QSR class 3 FDA certification process as project manager for the Benchmark Thailand facility pace maker RF head magnet for Medtronic’s stimulator.
Benchmark Electronics 2007- 2009 Customer Abbott Diabetes
• Project Engineer (glucose monitor) leading customer complaint and field investigation for Abbott Diabetes care as it pertains to NPI activity managing continuous improvement efforts utilizing Six Sigma Black Belt knowledge fishbone analysis and FMEA’s and other DMAIC principles utilizing statistical tools such as Minitab.
• Drive improvement back into the process of a high volume/ low mix line for consumer based product pull testing the heat seal process as well as preparing and analyzing prior to IQ/OQ/PQ change activity for numerous product improvements
• Liaison between the OEM development team and Thailand CM team managing the writing/creating of multiple integrated process and scope documents to include 510k and documentation of new products for Abbott Diabetes.
• Support war room team effort detailing processes, eco and validation activity concerning change and mediating between CM and OEM for FDA audits.
Benchmark Electronics 2005- 2006 Customer Boston Scientific (formerly Guidant)
• Accountable for incorporating deliverables for (bed side deliberator) oversee NPI activity to launch $30 million per year QSR class 3 medical products
• Communicate validation project management status to key stakeholders concerning schedule, material, and cost of test equipment quotes and build status. Benchmark Electronics 2004- 2005 Customer Medtronic’s
• •Introduce low volume proto type medical products for Medtronic’s DBS Deep Brain Stimulus creating validation plans from requirements and executing the protocol to generate the report.
Celestica, Salem, NH 2000 – 2004 NPI Optical Test Engineer
• Developed a Failure Analysis lab in house for Cisco networks fiber optic equipment by conducting feasibility studies, presenting needs analysis to company management, supervising setup of facility and the technicians staffing the program, collaborate with global design organizations.
• Teamed with three Fortune 500 customers to project manage transition to Celestica 24 hour manufacturing/test department. This involved leading project management and training 45 staff members over 3 shifts.
• Improved cumulative first pass yields 7% to maintain less than 2% scrap for Six Sigma project to reduce scrap
• Managed the entire functional, environmental stress screen (HALT/HASS), and final test area to include timely repair of process failures to Bellcore standards.
• Communicated at all organizational levels to customers and vendors.
IRobot (1999-2000) Manufacturing/Test Engineer Spike Technology (1998-1999) RF test
Monarch (1998-1998) Customer Service Technician
Tektronix’s (1996-1998) Optical test experience
Micro Wave Radio (1993-1996) RF test experience
Frequency Sources (1988-1993) RF and microwave electronic technician
EDUCATION
MBA, Southern New Hampshire University, Manchester, NH
BS, IT Management Daniel Webster College, Nashua, NH
ASEE, Technology, South Plains College, Lubbock, Texas
Certified Six Sigma Black Belt BMGI training
SIGNIFICANT QSR PROJECT ACCOMPLISHMENTS:
Benchmark Electronics (Thailand) public company QSR Registration 300-***-****
New product introduction Project Lead PMA
Class 3 FreeStyle Navigator® Continuous Glucose Monitoring System - P050020
New product introduction Project Lead PMA
6481 Inductive Communicator programmer, pacemaker Class 3
Senior Test Engineer major contributor
Implantable pacemaker pulse-generator 2090w (wireless) programmer Class 3
2067 RF Head; 2090 ECG Cable; 2090/2090X Touch Pen Stylus;
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