Senior Advanced Manufacturing Engineer
2 weeks ago
Life Unlimited. At Smith+Nephew, we design and manufacture technology that takes the limits off living.
The Senior Advanced Manufacturing Engineer 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, projects and interact daily with our Quality, R&D, and Manufacturing teams in Pittsburgh's growing Strip District.
What will you 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 work; 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 driving 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.
What will you need to be successful?
- BS (MS preferred) in Engineering or related field + 5+ relevant years.
- 3 years of experience in a manufacturing environment releasing and/or updating products.
- 3 years of experience in a medical device or relevant related industry.
- 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)
- Thorough 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 create and share project plans using MS Project
- Ability to collect data and apply 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.
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 ).
- 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.
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