Principle Design Assurance Engineer Resume Plymouth, MN - Hire IT People

PROFESSIONAL SUMMARY

Worked with a number of engineering companies in the medical, photography, PC hardware, space, and aerospace industries.
A proven track record of setting project goals and successfully leading them from inception to completion. Utilized SPC and six sigma tools to successfully establish considerable improvements in yield and reduction in product operations and support costs.
Dedicated to professional development through training in quality system requirements and medical industry practices that conforms to US FDA 21 CFR 820 GMP Quality System Regulation and ISO 14971 Risk Management standards.
Dedicated team player with extensive planning, organizational, technical writing, training, and effective communication abilities.

PROFESSIONAL EXPERIENCE

Confidential, Plymouth, MN

Principal Design Assurance Engineer

Responsibilities:

Extensive participation in medical device Product Development Process starting with customer needs through post market surveillance.
Leading the development of product risk management and risk mitigation planning and execution.
Leading development of Failure Mode Effects and Criticality Analysis such as UFMECA, DFMECA, and PFMECA.
Defining and developing design and process verification and validation test methods planning and strategy.
Extensive data analysis to confirm that products meet the requirements set forth.
Make recommendations for changes to product specification, verification and validation plans, protocols, reports, and tolerances.
Assist in the development of QA/QC policies and procedure to ensure department efficiency and compliant to appropriate regulations.
Provide clear concise documented evidence of the quality of product to certify compliance with regulatory bodies.
Consistently added value by utilizing risk assessment and management tools to halp shape the design selection and through utilizing outside the box thinking.
Design assurance lead core team member on multiple projects ranging from delivery systems, grafts, embolic protection, renal denervation, to ablation catheter medical devices.

Confidential, Minnetonka, MN

Senior Quality/Test Engineer

Responsibilities:

Developed and established scanner Quality Assurance/Control systems, utilizing extensive leadership abilities to ensure attainment of set process Six Sigma level goals from manufacturers.
Developed, managed and maintained audit test plans, procedures, and data analysis.
Developed and implemented corrective and preventive actions CAPA.
Maintained a real - time tracking system of manufacturing line “critical to function parameters” and hence isolated intrinsic assembly and design issues.
Established and maintained field data analysis system through utilizing Pareto charting, identified major issues that required corrective actions.
Improved manufacturing quality by 100% which reduced warranty claims by 90% in a 5 year period through implementation of SPC tools.
Identified potential failure mechanisms utilizing Failure Mode and Effects Analysis.
Developed and managed product environmental, vibration, image quality, robustness and accelerated life testing.
Drove implementation of process and design improvements.

Confidential, Hutchinson, MN

Advanced Development Engineer

Responsibilities:

Developed and maintained a comprehensive plan that ensured compliance of the Suspension Development Lab with ISO 9000 Quality Management System.
Established a set of guidelines that secured repeatability and consistency in testing.
Developed a set of controlled procedures which delineates in detail the theory and methodology for various tests performed on disk drive’s magnetic head Suspension Assembly.
Led and successfully completed a study that evaluated Error Budgets and the Uncertainty in Measurements, in the Suspension Development Lab, utilizing the ISO 9000 approach.
Designed, developed, and managed a number of databases in Lotus Notes.
Equipment Test Engineer for the Stiffness, Surface Analysis, and Ultrasonic testing.
Developed math models, test plans, and testing methods for various tests.
Tutored in math and physics.

Confidential, Huntsville, AL

Senior Engineer

Responsibilities:

Developed test implementation plans, test procedures, test reports, and test schedules.
Participated in project reviews and milestone developments for the Space Shuttle and the Space Station hardware testing program.
Designed and developed general operating procedures for a number of data acquisition and load control systems.
Established strain gage and electronic displacement transducer installation procedures, which were utilized in the AFT Shuttle External Tank/Orbiter interface hardware and the Space Station Common Module proof pressure test.
Developed a number of calibration procedures for various instruments utilized in testing, and was involved in static structural testing of the Space Station and Space Shuttle hardware.