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Yyyyyy x. yyyyyy

Xxxxxx, XXXXXX xxxxxx (xxx-xxx-xxxx


Program Management Specialist Multi-Project Leader Medical Device Expert


  • Dynamic Leader who offers a background in Multi-Program / Project Management, Product Development, Team Building, Global Production, Product Technology Transfers, OEM Design / Transfers, Regulatory Compliance, Risk Management / FMEA, and Patent / Litigation Case Defense, and exhibits an ability to see the big picture.
  • Top Performer who boasts above-average career results, and can make decisions to reflect positively on operations in alignment with a company s vision, value, and goals to attain a competitive advantage in the design / proof of concept, productization, remediation, validation, product, and field support of Class II III PMA and 510K devices.
  • Excellent Communicator who builds and sustains synergistic relationships with C-level executives, engineering / operational teams, vendors, and regulatory agencies, and can bring years of multi-functional project experience both internally to the company, as well as collaborating with outside OEM design and manufacturing companies.


Professional Synopsis


St. Jude Medical, Plymouth Maple Grove Minnetonka, XXXXXX 1999 2015


Cardiovascular Division

Senior Program Manager (2006 2015)

  Capitalized on the opportunity to lead multiple product areas, including lead placement guidewires, electrophysiology diagnostic catheter clinical studies, tissue valve delivery systems, renal denervation catheters, and Introducer Vascular Access with previous responsibility for a Next-Gen Vascular Sealing Device product line.

  Performed inner company, as well as influential outside vendor project planning, for critical on-time execution.


  Managed all associated multi-functional disciplines leading to US and OUS product launches.

  Participated in continued corporate-level training, field, design, and manufacturing product support.


Cardiovascular Division

Project Manager Core Team Leader (2005 2006)

  Utilized broad scope of industry knowledge and dynamic business acumen toward directing four multi-disciplinary projects, including exhibiting proficiencies in driving success of a new vascular closure device iteration introduction for a current product line with a vascular closure device s continuous improvement project.


  Led teams in achieving cost-savings updates to the vascular access product line.

  Successfully co-led the introduction of new Corporate Product Development Plan.

  Demonstrated experience in liaising among multi-functional groups from multiple facilities.

  Led investigations and recommendations for Introducer Product Line transfer to OUS OEM facility.


Cardiology Division

Principal Product Development Engineer (1999 2004)

  Strategically steered innovative product development concept thru to introduction and support, including driving planning, design, testing, and validation, as well as facilitating design input / output and risk analysis.

  Handled all FMEA, IFUs and engineering documentation for FDA-PMA, TUV, and BSI, as well as submittals for Class III restorable vascular sealing devices.


  Contributed talent in device development, packaging design, and clinical trials.

  Completed training in QSR / ISO as an integral Internal QA audit team member.



Yyyyyy x. yyyyyy Resume Page (xxx-xxx-xxxx


Kendall Health Care Tyco Company, Bothell, WA 1995 1999


Project Leader Senior Biomedical Engineer

  Spearheaded product design and development engineering for a state-of-the-art project encompassing new iteration designs and improvements to current vascular sealing device and packaging product line, including handling regulatory submissions, completing FDA inspections, facilitating cost reductions, and performing core investigations.


  Redesigned product lot release test equipment to reduce product loss.

  Generated increased product performance and significant cost reductions.

  Completed design technology transfer from partner company, design completion, and implementation into manufacturing of FDA PMA-regulated medical implantable, resorbable device.

  Designed device and packaging, change board, shelf-life studies, engineering submission reports, and manufacturing design issues, and successfully led results-focused vascular sealing product launch.


SpaceLabs Medical, Inc., Redmond, WA 1993 1995


Advanced Product Development Department

Project Manager Biomedical Engineer

  Led targeted decision-making toward directing a results-focused team of four engineers and technicians, including facilitating product development and technology transfer of blood gas and ion based in-vitro electrodes, as well as developing a biocompatible gasket seal for buffer/blood path and completing documentation and functional tests.

  Ensured seamless processes by supervising a chemistry lab responsible for research / development and production.


  Cost-effectively prepared budget and capital equipment acquisition plans.

  Conceptualized, developed, and implemented project plans and maintained strict schedules.

  Completed two successful electro-chemical technology transfers to achieve in-house capabilities.


Abbott Research, Inc., Bothell, WA 1984 1993


Hospital Products Division ACCS Abbott Laboratories

Senior Product Development Engineer Clinical Research Associate OBpH Product

  Drove division success by completing Biocompatibility Implant bench and animal studies; Optical-Based Continuous Fetal Scalp Tissue pH Sensor development; design of product, packaging, and manufacturing qualification thru launch; and pre-qualification testing of Optical Continuous Blood Gas Monitoring Probe / System.


  Completed two Phase I NIH grants and one Phase II NIH grant.

  Developed multiple sensors on a single optical fiber that led to a successful patent.

  Designed Optical-based Continuous Tissue Chemical Analyte Monitoring Probe / System.


Education, Professional Development & Technical Summary


Bachelor of Science in Biological Sciences South Dakota State University

Project Management Professional (PMP) Training PMBOK Project Management Institute (PMI)


Cardiovascular Product Area Submission Type

Vascular Closure Femoral Closure Device PMA FDA CE TUV / BSI

Vascular Access Sheaths Dilators 510K

Percutaneous Valves Delivery Systems 510K

Electrophysiology Diagnostic Catheters Clinicals IDE / OUS

Diagnostic Catheters Software Clinical Studies

Peripherals Renal Artery Ablation Catheter 510K TUV / TGA

Blood Gas Monitoring Continuous Monitoring Catheter PMA


Patent Information Provided Upon Request Excellent Professional References Provided Upon Request

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