Advanced Manufacturing Engineer NPD

Overview

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.

U.S. Sponsorship or H1B transfer is not available for this role.

Responsibilities

• Create manufacturing deliverables for New Product Development projects, lead New Product Development efforts
• Support development and implementation of production test solutions for manufacturing including functional test, electrical safety test, calibration, leak test, etc. by designing and building test fixtures, tooling, and software-based automation systems.
• Design, develop, construct and implement tools, fixtures, and gages
• Select and qualify equipment and create calibration/preventative maintenance specifications
• Coordinate activities between the NPD and Product Support R&D teams and downstream manufacturing sites
• Create and revise work instructions, BOMs, and routers
• Execute design transfer process deliverables; capture the voice of the factory in design for manufacturability reviews and design transfer meetings
• Lead process validation efforts (IQ/OQ/PQ/TMV) along with quality team support, including authoring and executing protocols as required
• Help develop Capital Expenditure requests for new equipment, tooling, and gauging
• 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.

Minimum Qualifications

• Education
  • BS (MS preferred) in Engineering or related field + 3+ relevant years
• Experience
  • 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

Preferred Qualifications

• 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 developing test systems, including familiarity with robotic systems, motion control systems, data acquisition systems, embedded programming, etc.
• Familiarity with programming tools like LabVIEW, Python, C, C++, and/or MATLAB for automation and data collection.
• Experience working in a manufacturing environment releasing and/or updating products, as well as troubleshooting complex technical issues
• 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
• Knowledge and understanding of GD&T

Travel: <10%

Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.