Advancedmanufacturing Engineer 2 - NPD

Advanced Manufacturing Engineer Ii

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.

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

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 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
• 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. Stay connected by joining our Talent Community. Smith & Nephew is an Equal Opportunity/Affirmative Action Employer -EEO/AA/Minorities/Fem les/Disabled/Veterans and participates in the E-Verify Program. As an equal opportunity/affirmative action employer, Smith & Nephew is committed to a diverse workforce.