As a systems engineer, displays standard system engineering principles and techniques (Requirements Management, Risk Management, Configuration Management) to resolve difficult problems, from conception to final design with team input. Plans and leads project assignments in the evaluation, selection and adaptation of various engineering techniques procedures and criteria with minimal guidance.|
Specific responsibilities include:
* Lead development of Design Inputs and risk management strategy
* Work with cross functional team members (e.g. Marketing and Clinical personnel) to translate user needs into system requirements.
* Lead engineering resources (Electrical, Mechanical, and Software) in the decomposition of system requirements to derived requirements.
* Define transfer functions to capture system behaviors, and support modeling and simulation activities.
* Through transfer functions resolve interface issues and to document theory of operations documentation.
* Define test strategies to allow the development of verification plans and validation plans using requirement tracing methods.
* Lead risk analysis activities from the capture of inherent hazards through mitigation, including quantitative residual risk calculation in support of the Safety Assurance Case.
* Implement configuration management through the complete product life-cycle, including design, development, and sustaining phases.
* Interface with Manufacturing, Service, Product Surveillance, Supply Chain, and Customer Training staff through the design transfer process.
* Ensure compliance to the product development process and Quality System.
* BS degree in Engineering or Science field with approximately 5 to 8 years of relevant experience.
* Electromechanical Medical Device Design experience is strongly preferred.
* Requires strong organization and communication skills, with the ability to interface with both technical and non-technical personnel.
* Must be able to provide solutions that reflect understanding business objectives and cost implications.
* Experience with requirements management tools, design control requirements (21CFR 820.30, ISO 13485), and risk management (ISO 14971) is strongly preferred. Design for Six Sigma (DFSS) and/or formal Green/Black belt certification a plus.Baxter provides its employees with comprehensive compensation and benefits.To view other opportunities at Baxter and to learn more about the company, please visit our Web site at http://www.baxter.com/about_baxter/careers . EOE M/F/D/V.
axter International Inc. (NYSE: BAX), is an American health care company with headquarters in Deerfield, Illinois. The company primarily...