Senior Project Engineer Resume Cleveland, OH - Hire IT People

SUMMARY

Skilled electrical engineer with 20+ years experience in medical device development. A highly motivated, hands on team player who enjoys interfacing with people at all levels of an organization. Recognized for engineering troubleshooting leading to on time and on budget projects. Demonstrated accomplishment in:
Circuit design, both analog and digital
Printed circuit board (PCB) layout
System - level design and prototyping
Troubleshooting and debugging circuits
Engineering project management
Electrical safety testing
Design verification and validation
Design for manufacturing and production support
Developing product specifications
Design submission for FDA and CE Mark

PROFESSIONAL EXPERIENCE

Confidential, Cleveland, OH

Senior Project Engineer

Responsibilities:

Served as integral member of an inter-disciplinary team that developed an active implantable medical device system providing spinal cord stimulation to treat chronic pain. Involved in the project from initial concept development through market release of the system.
Functioned as primary engineer responsible for the hardware design of a tablet computer used by medical clinicians to program stimulation devices via wireless communications. The tablet was based on an i.MX515 processor and included a color touch-screen display, audio output, a 5MP camera, a Micro-SD card, RF interfaces for MICS, WiFi, and Bluetooth, communication ports for USB, JTAG, and HDMI, and charging and cell protection circuitry for a Lithium-ion battery.
Worked with team members across the organization to create system-level and design-level specifications. Generated all design-level documentation including schematics, BOMs, gerbers, and fabrication drawings. Transferred the design to an external company for manufacturing and final product release.
Created documentation needed for verification and validation testing as well as documentation needed for regulatory submission to FDA and for CE mark.
Provided support to the teams working on other parts of the system by performing design updates and PCB layout fixes for other external programmers and the implantable pulse generator.

Confidential

Project Engineer

Responsibilities:

Provided hardware design support for innovative medical technologies that were spun out of various research centers in Cleveland and elsewhere in the United States, with a focus on pushing these technologies from feasibility to product release.
Provided design and layout support for a low-power hand-held pneumothorax detector based on the PXA320.
Designed a miniaturized amplifier circuit for measuring EEG, EMG, and ECG signals as low as 10µV.
Supported the feasibility phase development and hardware prototyping for various other electromechanical projects. Worked closely with mechanical and software engineers on these efforts.

Confidential, Cleveland, OH

Senior Engineer, X-Ray Engineering

Responsibilities:

Engineering Project Leader of a cross-functional team that developed a new radiographic servo tomography medical imaging system.
Developed system-level, design-level, and test specifications for the new system.
Supervised the product development to meet all regulatory requirements for safety, including ISO 9001, UL, IEC, and FDA requirements.
Ensured that all milestones were met on schedule and within budget.
Communicated directly with field service engineers to evaluate failures and improve product reliability and reduce installation time. This resulted in a 100% increase of the MTBF and a 50% reduction of the installation time.
Lead engineer responsible for designing non-standard products and interfaces that allowed older systems to be upgraded.
Performed root cause analysis of failure modes and designed new circuitry to eliminate failures and improve reliability. Also supported the design control process by evaluating the impact of design changes.
Wrote engineering-level and field-level test procedures for the release and implementation of specialized products.
Assembled and tested various analog and digital circuits. Assisted engineers with circuit design as needed.
Developed and evaluated the system interface for new products.
Contributed to the development and release of 14 different medical imaging systems.