Sr. Manufacturing Engineer

AGA Medical Corporation, a medical technology company, is dedicated to the development, design, manufacture, and marketing of nitinol-based occlusion devices and accessories for the minimally invasive treatment of cardiovascular defects and peripheral vascular disease.As a Sr. Manufacturing Engineer, you will provide Lean and Six Sigma process development solutions and assists in new product introductions from a robust new product pipeline. Focus on improving existing production lines as well as assist in the transfer of new process into manufacturing utilizing lean methodologies Utilize Process Failure Mode Effects Analysis (PFMEA) and DOE’s to analyze manufacturing processes for optimization Work effectively in a cross-functional team environment and have experience in executing portions of a Product Development Protocol if required Utilize project/program management skills to communicate status of projects Author specifications, justifications and implementation of capital projects Coordinate the design, procurement, build and debug of component tooling, assembly tooling/machinery and/or test equipment required to produce new and existing products Author IQ, OQ and PQ protocols in addition to performing process validations Interface with component suppliers to resolve manufacturing and quality issues Ensures proper documentation is completed to meet quality system requirements (i.e. PFMEA’s, travelers, written manufacturing processes, process validations etc.) Work closely with production to ensure that manufacturing goals are met Train and/or provide work direction to technicians and will train manufacturing personnel Qualifications: Bachelors of Science degree in a engineering discipline, preferably a Mechanical, Metallurgical or Materials degree - Experience with automation, vision or robotics a plus 8-10 years experience in process development - medical devices experience a plus Preferred experience in metallurgy, joining and forming technologies and knowledge of nitinol Must have a working knowledge of Design for Manufacture (DFMA), Process FMEA, Process Validation, Project Management, Lean methodologies, DOE, SPC and Gage R&R, process qualification/validation and design transfer Working knowledge of basic PC programs (Word, Excel, Power Point, VISIO, Access etc.) and experience using DOE or SPC programs Excellent data analysis skills Excellent patience and communication skills across cultures Experience with tool design, automation and lasers highly desirable Occasional lifting up to 50 pounds Ability to use a microscope -For quick consideration apply here We offer an excellent compensation and benefits package including medical, dental, life insurance, disability, 401(k), and much more. An Equal Opportunity/ Affirmative Action Employer Please, No Agencies Position Information Location: Plymouth, MN Job Category: Engineering Contact Information reference code: 1185