Supplier Quality Engineer - NPD (EE) (EBD)

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 This position will be responsible for Supplier Quality Engineering responsibilities as they apply to New Product Development projects for Energy-based Devices and Energy Delivery Systems; Supporting internal and external product development efforts, and supporting other Internal Quality initiatives as necessary. Working on the Quality team across multiple product development projects this position will employ the use of Product Development Process (PDP) and six sigma tools to ensure that compliance with Design Control and Corporate quality requirements are met, assuring our commitment to producing safe and effective products. This position may be called on to improve external processes and products, utilizing Six Sigma concepts and tools. This position is set in a fast-paced environment and will require the ability to work on diverse cross-functional teams.ESSENTIAL DUTIES AND RESPONSIBILITIES:• Participates in developing sourcing strategies on new productsWorks with design teams to understand and provide DFx input to specificationsCommunicates specifications and quality requirements to suppliers Designs parts of prototype systems for new products/processes.• 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 cost and 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.• Provides cost and activity accounting period reports 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 standards.• Writes 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.• Prepares verbal presentations for various company meetings.• Develops and writes specifications for components/systems, product, processes, and packaging/labeling.• Maintains a clean, safe, and orderly work area.• Follows all safety procedures.OTHER DUTIES AND RESPONSIBILITIES:• Performs other duties and responsibilities, as required.PRINCIPAL WORKING RELATIONSHIPS:• Works with other engineering personnel to create and develop engineering prototypes of new products/processes.• Works with RA, QA and Documentation departments to establish proper regulatory and quality documentation procedures.• Works with engineering personnel on production problems and changes as necessary.• Works with Marketing and cross-functional teams to define and introduce new products. • Works as a team leader (and as a team member when required) in the development of engineering designs and tests.• Supplies Purchasing Department with specifications regarding purchased parts and OEM products/processes.• Works with Safety, Health and Wellness, affected employees, and other necessary resources to ensure the highest feasible level of safety and hazard control.• Works directly with finish goods suppliers in all aspects of product/process development, release, and sustaining activities.Requirements: Bachelor’s degree in Electrical Engineering or related curriculum required. Preferred: Master’s degree in Electrical Engineering, or related field.The candidate must be detail oriented and able to work efficiently, with 5+ years experience in a Supplier Quality Engineering function with a focus on new product development. The candidate should possess broad project and process knowledge, including a broad range of experience with electronic commodities and complex systems.Medical device, pharmaceutical, and/or R&D experience/background is highly preferred, with working knowledge of GMPs, Design Controls, FMEA, SPC, failure investigation/OOS and risk analysis processes.Working knowledge of ISO13485, 21 CFR Part 820 Quality Systems, 21 CFR 210/11 cGMP. Strong analysis and problem-solving skills, including SPC, DOE, Statistics, Kaizen, etc. Six Sigma Certification preferred. At a minimum, experience with Measurement System Analysis and Process Validation tools / methodologies to include Process Capability studies.Requires excellent interpersonal and group communication skills (including presentation skills) to deal effectively with project teams, various internal functions and suppliers. This position may require domestic and international travel 10-15%. 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.