Advanced 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 leading the launch of new 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 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 offers involvement in a wide range of activities and projects, with daily collaboration across Quality, R&D, Product Support, and Manufacturing teams. It is based 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?

• Build 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
• Build and revise work instructions, BOMs, and routers.
• Design, develop, construct and implement tools, fixtures, and gauges.
• Implement design transfer process work; 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 completing 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 build calibration/preventative maintenance specifications.
• Analyze production risk 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, actively participate in schedule development efforts 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 3 years proven experience.
• 2 years’ experience in the medical device industry or relevant related industry.
• 2 years’ experience working in a manufacturing environment releasing and/or updating products.
• 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 solving sophisticated 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.
• Knowledge and understanding of GD&T.
• 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.
• 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 and Adoption Assistance Program
• Flexibility: Hybrid Work Model (For most professional roles)
• Training: Hands-On, Team-Customized, Mentorship
• Extra Perks: Discounts on fitness clubs, travel and more!

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.