Chiahsin Chen Email & Phone Number

Linköping, Ostergotland County, Sweden

Lake Zurich, Illinois

Client: Fresenius-Kabi (Located in Lake Zurich, IL USA)-Led feature development of web-based applications and supported FDA submission.-Developed requirements, architecture design, detail specifications, maintenance and verification process of the software used for infusion devices. -Collaborated with others to provide analysis of proposed designs based on use case scenarios and various other inputs. Delegated requirements analysis activities to cross functional teams or other system engineers as appropriate for product definition.

Round Lake, Il

Product Design Engineer (Client: Baxter)-Conducted approved medical device projects and made suggestion on improvements based on recent technical knowledge-Contributed to cost estimating of major capital budget items and the spending of approved project funds-Contributed to the planning and execution of components of the development process, which apply to product revision or enhancement or a defined piece of a large project-Managed routine projects and investigated/analyzed customer service problems and design improvement suggestionsSystem Engineer (Client: Hospira/ICU Medical Inc.)-Created allocation of design input to subsystem level specification and tracing of at all levels of requirements flow down using DOORS® and Magic Draw®-Constructed requirement specifications in accordance with FDA and ISO standards-Worked in a team to bring products from cradle to grave, presenting final solutions to management and cross functional teams-Coordinated use case development through needs analysis based on customer specifications-Conducted system verification planning, protocol development, test execution and reporting-Delegated requirements analysis activities to other Systems Engineers as appropriate for Product definition-Designed high level system architecture with focus on requirements allocation and traceability-Analyzed medical device development using ISO 14971 for hazards analysis, design Failure Mode Analysis, Fault Tree analysis, and Risk Control Development

Houghton,Mi

• Conducted literature reviews and collected/analyzed data. Verified the accuracy and validity of data entered in databases; corrected errors• Facilitated gathering of materials and data for various projects and reports; wrote summaries of project findings as requested. Edited and submitted protocols and other required research documentation

Master'S Degree, Biomedical/Medical Engineering, 3.5

Bachelor'S Degree, Biomedical/Medical Engineering, 3.53

Activities and Societies: Student Council of the Department of Biomedical Engineering-Chief of Guidance Counseling Taiwan Fund.