Medical Device Quality Engineer Resume
A medical device quality engineer is responsible for identifying the requirements of and improving the quality of medical devices. He is also hired for evaluating functionalities, and validating the prototype of medical devices. The role also demands modifying/improving the existing medical devices to expand its applications. The job duties of this position include researching and developing strategies, planning, and implementing various processes to improve the manufacturing technology. It is also the duty of a medical device engineer to provide safety guidelines and procedures to end users.
Medical Device Quality Engineer Resume Example
Robert N. Demuth
2695 Smith Road
Lilburn, GA 30247
Phone: 770-921-9366
Email: rndemuth@example.com
Career Objective:
Individual with thorough experience about validation protocols, risk assessment and product development cycles of medical devices, intends to work as a medical device quality engineer for a leading organization.
Summary of Skills:
- Comprehensive knowledge of product development life cycle, risk assessment, and validation protocols
- Extensive knowledge of methods and process of medical device design control
- In-depth knowledge of the concepts of engineering change control, statistical techniques, and IQ validation protocols
- Well-versed in the methodologies of software validation and verification, sterilization processes, and FDA (21CFR 803/806/820)
- Familiar with FDA Quality System Requirements/ISO 13485, Six Sigma, quality auditing, and engineering drafting
- Sound knowledge of Solid Works, ISO (ISO: 13485) regulations, Gage R&R, and Pro Engineering concepts
- Well-versed in communicating effectively with knowledge of basic computer applications
- Hands-on experience in testing quality of medical devices for various applications with sound knowledge of standard quality testing
Work Experience:
Medical Device Quality Engineer
Eilliam Medical Equipment, Inc., Lilburn, GA
October 2014 - Present
- Developing testing methods, writing quality testing procedures, and checking quality to ensure compliance
- Guiding quality assurance engineers in IQ/OQ/PQ activities and validation process
- Planning and implementing quality testing procedures, scheduling project plans, and preparing documents
- Generating techniques of quality-engineering to test medical devices
- Handling customer queries and ensuring customer satisfaction by providing effective services
- Executing validation activities as well as provide support to the staff to achieve project milestones
Junior Medical Device Quality Engineer
Pigeon Medical Services, Lilburn, GA
February 2013 - September 2014
- Providing support to the senior medical device engineers in manufacturing and installing medical devices
- Developed new processes for testing various parts of medical equipment and devices
- Provided effective support in all the stages of product development by applying quality engineering applications
- Assisted senior medical device engineers in creating test case strategies
- Performed root causes analysis of failures in electrical and mechanical parts
Education:
- Bachelor's Degree in Electronics Engineering
ABC University, Lilburn, GA
2012
Reference:
On request.
