Staff Operational Technology Engineer

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

The Staff Manufacturing Systems Engineer is part of our site Operational Technology (OT) team in Memphis, Tennessee and is responsible for identifying, implementing, and supporting digital manufacturing projects across the Smith + Nephew Memphis campus with a focus on implementing Manufacturing 4.0 initiatives that include the Industrial Internet of Things (IIoT), production monitoring/control, data analysis, and factory simulation.

The Staff Manufacturing Systems Engineer will work globally with multi-functional teams and external contractors in the successful development of various manufacturing systems to support the goals and objectives of Smith+Nephew. This position ensures that timeline landmark commitments are achieved while meeting all Safety, Quality, and Cost requirements and for achieving performance targets for efficiency savings and value.

What will you be doing?

• Lead development on strategic projects and collaborate multi-functionally with IT, Operational Excellence, Data Analytics, and Operations to deliver robust solutions that expand the capabilities of Smith+Nephew’s manufacturing systems globally.
• Ensure cost, quality, and timing efficiencies are achieved. Understand user needs and translate into technical requirements.
• Partner with Manufacturing IT to develop, implement, and support IT/OT architecture, standards, and governance.
• Identify, evaluate, and implement technologies and tools for automated data gathering and analysis, including IIoT and data visualization technologies.
• Provide Design for Automation recommendations to New Product Development (NPD) Manufacturing Engineering team regarding design concepts and manufacturing processes to best use Manufacturing 4.0 capabilities.
• Provide technical solutions and improvements to manufacturing processes and ensure cost and quality expectations are met.
• Ensure processes and procedures align with regulations.
• Drive through challenges to deliver on commitments and meet team and individual savings targets.
• Present to Operations Technology Vice President and Site Leaders as needed.

What will you need to be successful?

• Bachelor’s degree in science or engineering.
• Minimum 5 years’ professional work experience in Manufacturing Engineering, Operations Technology, or Manufacturing IT
• Experience implementing IIoT communication protocols such as OPC/UA, MQTT, HTTP/REST, etc.
• Strong knowledge of networking, IT/OT architecture, and security concepts.
• Experience in either a direct or consulting role in medical device/biopharma sector or project.
• Understanding of medical device requirements for software validation, Installation Qualification (IQ), Operation Qualification (OQ), and Process Qualification (PQ) as it related to production equipment validation.
• Understanding of Programmable Logic Control (PLC) configuration and networking.
• Experience implementing/administering Tulip Interfaces, PTC KepServer, and/or other digital factory software packages.
• Proven record for delivering automated solutions for optimizing & improving processes (manufacturing 4.0 technologies)
• Able to communicate effectively in English.
• Familiarity with requirements of GAMP 5 and other key Medical Device industry standards/regulations including FDA 21 CFR Part 11, FDA CFR Part 920, ISO 14971, ISO 13485, ISO 9001, and EU MDR.
• 5% Travel

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: