SR. QA ENGINEER

Manufacturing/Production/Operations       Total Work Experience: 5+ to 7 Years Job Description The Energy-based Devices Global Business Unit of Covidien is the world leader in the innovation and manufacture of advanced energy-based medical systems. Founded in 1967, our company remains unsurpassed in developing electrosurgery and radiofrequency treatment systems that increase patient safety and provide solutions for challenging surgical problems. Covidien’s Energy-based Devices Global Business Unit has maintained a campus in Boulder, Colorado for 40 years and continues to build a culture rich in organic growth and development worldwide. Our company places a strong emphasis on people, products, and process to continue driving our success. The launch of Covidien better equips us to meet the diverse needs of customers and to reaffirm our commitment to be an employer of choice in Colorado. More information can be found at www.covidien.com The Senior Engineer, RQA (Process Validation Engineer) is one of creation and innovation which leads to the development and introduction into production of new products/processes. The Senior Engineer, RQA may be responsible for: a) product/process development projects, product/process introduction, sustaining and enhancing existing product/process, production trouble shooting, or individual measurement and analysis projects; b) performing measurements, developing plans and keeping laboratory notebooks on all projects; c) functioning as a member or at times as leader of cross functional teams; d) preparing time estimates for projects, overseeing entire projects or subprojects.•Performs engineering measurements and analysis.•Records work in laboratory notebook.•Contributes to and executes engineering schedules and plans.•Instructs engineers and technical support staff on engineering test and build requirements.•Prepares time estimates for engineering and project schedules.•Supervises and prepares laboratory technician tasks and projects as required.•Provides written reports and engineering documentation as necessary.•Executes tactical implementation of strategic plans. •Assures compliance with company Standard Operating Procedures and policies.•Participates in team decision making.•Develops team problem solving and communication skills.•Demonstrates skill in the use and care of all tools and equipment.•Demonstrates knowledge and understanding of Good Manufacturing Practices and all other applicable standards.•Stays informed about applicable new rules, regulations, and standard•Approves engineering test protocols for testing of component parts and integrated systems.•Assesses OEM/Contract Manufacturing capabilities, as required.•Prepares engineering assignments, as required.•Oversees the preparation of Change Order System and the signature process.•Prepares monthly progress reports on projects.Requirements: Knowledge of process validation requirements for Medical Device Manufacturing. Ability to demonstrate utilization and understanding of six sigma continuous improvement tools. Ability to carry out engineering calculations and analysis and to write engineering documents, test protocols, laboratory notebook entries and reports. Ability to lead teams through complex projects. •Required: Bachelor’s degree in Mechanical or Electrical Engineering, or related field.•Preferred: Master’s degree in Mechanical or Electrical Engineering, or related field.Five (5) years experience in engineering practice including project development responsibility. DISCLAIMER:The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.Covidien is an equal opportunity employer, M/F/D/V.To apply online, please use the following link: Apply To Covidien Click here to see all “Covidien� opportunities Visit our web site to learn more about Covidien EMAIL THIS JOB TO A FRIENDCOVIDIEN, COVIDIEN with Logo and "positive results for life" are trademarks of Covidien AG. ©2007 Covidien AG or its affiliate. All rights reserved.