R&D Engineer (PDP)

Helping Hearts Heal ThemselvesAGA 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 R&D Engineer, you will provide technical engineering to support product development and transfer of products to manufacturing through design, development, testing and documentation of new medical devices following in-place design control procedures. Design and develop new interventional medical devices following established design control procedures.
Generate the necessary documentation to convey design intent, including drawings, materials specifications, manufacturing procedures, BOM’s, inspection procedures and travelers.
Construct and evaluate prototype devices.
Write protocol and reports.
Maintain a detailed laboratory notebook.
Translate design inputs into engineering specifications.
Identify and establish relationships with key suppliers for research and development and production components.
Prepare timelines, cost analyses and resource needs.
Perform design and process validations.
Perform job functions in accordance with applicable GMP and ISO standards. REQUIREMENTS
BS in Engineering or equivalent experience.
One to three years R&D experience; medical device experience preferred.- Good written and verbal communication, record keeping and problem solving skills.
Demonstrated creativity and "hands on" prototyping skills.
Working knowledge of ISO, GMP and QSR; FDA experience is a plus.
Computer proficiency with Microsoft applications.
Ability to work independently and take initiative.
For a more detailed job description, please visit our website at www.amplatzer.com.We offer an excellent compensation and benefits package including medical, dental, life insurance, disability, 401(k), and much more.An Equal Opportunity / Affirmative Action EmployerPlease, No Agencies