Advanced Manufacturing Engineer 2 - NPD

Smith & Nephew•Pittsburgh, PA

49d

About The Position

We are a fast-paced, innovative manufacturing engineering team within Smith+Nephew Robotics working to launch new product development products to our partner manufacturing sites. We are seeking an Advanced Manufacturing Engineer II to help further our company's vision - "Life Unlimited". The successful candidate will be focused on delivering high-quality work on schedule to meet our commitments to the business with the goal of furthering the future of medical technology. This position will be involved in a wide array of activities and projects and interact daily with our Quality, R&D, Product Support and Manufacturing teams and is located in Pittsburgh's thriving Strip District.

Requirements

BS (MS preferred) in Engineering or related field + 3+ relevant years
At least 2 years' experience in the medical device industry or relevant related industry
At least 2 years' experience working in a manufacturing environment releasing and/or updating products

Nice To Haves

Experience working on New Product Development
Experience in the medical device industry or relevant related industry; experience with robotics and/or electromechanical products preferred
Experience working in a manufacturing environment releasing and/or updating products, as well as troubleshooting complex technical issues
Experience with qualification of plastic, metal, and electronic assembly processes
Understanding of process validation and the associated regulations (IQ/OQ/PQ)
Experience with Design for Manufacturability processes
Ability to collect data and utilize Minitab (or similar) to calculate process capability and perform Design of Experiments, Measurement Systems Analysis, and other statistical studies
Ability to design and fabricate simple production fixtures and tools
Understanding of Lean/Six Sigma methodologies and tools
Knowledge and understanding of GD&T

Responsibilities

Create manufacturing deliverables for New Product Development projects, lead New Product Development efforts
Coordinate activities between the NPD and Product Support R&D teams and downstream manufacturing sites
Create and revise work instructions, BOMs, and routers
Design, develop, construct and implement tools, fixtures, and gages
Execute design transfer process deliverables; capture the voice of the factory in design for manufacturability reviews and design transfer meetings
Lead process validation efforts along with quality team support, including authoring and executing protocols as required
Implement automation as appropriate for site
Help develop Capital Expenditure requests for new equipment, tooling, and gauging
Select and qualify equipment and create calibration/preventative maintenance specifications
Analyze production risk via PFMEA; create process maps and control plans
Analyze highly complex technical manufacturing problems and provide innovative solutions
Own and respond to CAPA investigations
Support engineering and prototype builds, actively participate in schedule development efforts for release of new designs to production
Support development and implementation of functional test solutions for manufacturing