Description:
Position Overview
Supports the manufacturing organization with process creation and maintenance. Works to identify root cause while troubleshooting electro-mechanical medical devices. Provides support in review of results to determine that products perform in the intended manner. Provides support in documenting product issues for future reference and problem resolution. Drives projects to increase productivity and reduce product cost.
Responsibilities
Evaluates designs and proposes revisions to improve manufacturability.
Identify manufacturing issues (design/process/component) and drive resolution by participating on cross-functional or project teams.
Research and resolve electro-mechanical, production assembly and/or test issues in a timely manner.
Define critical processes, develop assembly and test procedures, train production personnel, and verify effectiveness of process and training
Design, develop and validate test fixtures to be used in-house and at vendor sites
Supports cross functional teams in a collaborative environment
Required Knowledge/Skills, Education, and Experience
BS Engineering required
FDA/ISO/Med Device
3+ years experience
Qualified Applicants must be legally authorized for employment in the United States. Qualified Applicants will not require employer sponsored work authorization now or in the future for employment in the United States.
Preferred Knowledge/Skills, Education, and Experience
Experience with process FMEA
Lean Manufacturing
Experience with new product introductions and/or product transfers