Senior Manufacturing Engineer

Life Unlimited. At Smith+Nephew, we design and manufacture technology that takes the limits off living.

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 a Senior Manufacturing Engineer to help further our company’s vision – “Life Unlimited”. The successful candidate will be passionate about 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, and Manufacturing teams located in Pittsburgh's growing Strip District.

**This position does not offer visa transfer or sponsorship now or in the future**

What you will be doing?

• Act as the Manufacturing Engineering lead for New Product Development projects.
• Coordinate activities between the NPD R&D team and the downstream manufacturing sites.
• Build and revise work instructions, BOMs, and routers.
• Design, develop, construct, and implement tools, fixtures, and gauges.
• Implement design transfer process deliverables; collect 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 implementing protocols as required.
• Implement automation as appropriate for site.
• Lead efforts to submit Capital Expenditure requests for new equipment, tooling, and gauging.
• Select and qualify equipment and build calibration/preventative maintenance specifications.
• Lead production risk analysis via PFMEA; build process maps and control plans.
• Analyze highly sophisticated technical manufacturing problems and provide innovative solutions.
• Own and respond to CAPA investigations.
• Support engineering and prototype builds, create schedules action items for release of new designs to production.
• Support development and implementation of functional test solutions for manufacturing.

What you need to be successful?

• BS (MS preferred) in Engineering or related field and 5+ relevant years of experience.
• 3 years’ experience in the medical device industry or relevant related industry
• 3 years’ experience working in a manufacturing environment releasing and/or updating products.
• Experience releasing new product development projects while meeting schedule commitments.
• Experience in the medical device industry; experience with robotics and/or electromechanical products preferred.
• Experience solving complex technical issues in manufacturing and driving resolution via collaboration with R&D.
• Experience with qualification of plastic, metal, and electronic assembly processes
• In-depth understanding of process validation and the associated regulations (IQ/OQ/PQ)
• Detailed understanding of Design for Manufacturability and a proven history of using DFM tools to drive design change.
• Ability to lead and report on change in a structured way, including ability to build and share project plans using MS Project.
• Ability to collect data and use Minitab (or similar) to calculate process capability and perform Design of Experiments, Measurement Systems Analysis, and other statistical studies.
• Ability to craft and fabricate simple production fixtures and tools.
• Understanding of Lean/Six Sigma methodologies and tools.
• Proven knowledge and understanding of GD&T.
• Travel Requirement – 10%.

You. Unlimited!

We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.

• Inclusion, Diversity and Equity- Committed to Welcoming, Celebrating and Thriving on Diversity, Learn more about Employee Inclusion Groups on our website (https://www.smith-nephew.com/ ).
• Your Future: 401k Matching Program, 401k Plus Program, Discounted Stock Options, Tuition Reimbursement
• Work/Life Balance: Flexible Personal/Vacation Time Off, Paid Holidays, Flex Holidays, Paid Community Service Day
• Your Wellbeing: Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility