Principal Manufacturing Engineer

Helping Hearts Heal Themselves

AGA Medical Corporation specializes in the development and manufacturing of innovative medical devices for use in cardiovascular applications. AGA's patented AMPLATZER family of occlusion devices offers new and enhanced solutions for transcatheter treatment of complex congenital heart defects. We are a fast-growing, innovative company, looking for creative professionals to join our team.
As a Principal Manufacturing Engineer you will act as the technical leader for new process development activities directly associated with the development of new medical device platforms designed in a ISO/FDA regulated environment. This includes:

Utilizing Design for Manufacture, Six Sigma and Lean methodologies in the development of manufacturing processes to support new medical device product development projects and continuation engineering process improvement efforts.
Leading the effort for Process Failure Mode Effects Analysis (PFMEA) to be conducted on new product designs.
Working effectively in a cross-functional team environment and manage portions of the Product Development Process.
Authoring 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 products. REQUIREMENTS
Preferred candidates will have:

Bachelors of Science degree in an engineering discipline, preferably a Mechanical, Metallurgical or Materials degree. Advanced engineering degree a plus.
10-14 years experience in process/product development, minimum of 5+ years experience with medical devices. Manufacturing background preferred.
Preferred experience in metallurgy, joining and forming technologies and knowledge of nitinol.
Must have an effective 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, SPC and/or simulation programs.
The individual should be innovative, resourceful, work with minimal direction and should have excellent problem solving skills, oral and written communication skills and have strong team leadership/participation skills.