Senior Operational Technology Engineer

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

Smith+Nephew is looking for a Senior Operational Technology Engineer to join our Global Operations Technology (OT) team. This position is location flexible and may be remote.

The Senior Operational Technology Engineer, identifies, implements, and supports digital manufacturing projects across Smith+Nephew, 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.

You 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 according to strategic plans, ensuring that landmark commitments are achieved while meeting all Safety, Quality, and Cost requirements and for achieving performance targets for efficiency savings and value.

What you will be doing?

• Lead strategic projects, collaborating with IT, Operational Excellence, Data Analytics, and Operations to improve global manufacturing systems. Ensure cost, quality, and timing expectations are met. 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 technical support and maintenance for Global OT applications throughout the application lifecycle.
• Support site OT teams in development and implementation of local initiatives.
• Provide Design for Automation recommendations to New Product Development (NPD) Manufacturing Engineering team regarding design concepts and manufacturing processes to best apply Manufacturing 4.0 capabilities.
• Provide technical solutions and improvements to manufacturing processes and ensure cost and quality 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 you will need to be successful?

• BS in Engineering, Science, or related field
• Minimum 5+ years professional work experience in Manufacturing Engineering, Operations Technology or Manufacturing IT.
• Experience implementing IIoT communications protocols such as OPC/UA, MQTT, HTTP/REST, etc.
• Strong knowledge of networking, IT/OT architecture, and security concepts.
• Experience in either direct role in the medical device/biopharma sector or consulting work on a medical device/biopharma project
• Understand medical device requirements for software validation, Installation Qualification (IQ), Operation Qualification (OQ) and Process Qualification (PQ) as it relates to production equipment validation.
• Proven knowledge of Programmable Logic Control (PLC) configuration and networking
• Experience implementing/coordinating Tulip Interfaces, PTC KepServer, and/or other digital factory software packages.
• Proven track record for delivering automated solutions for optimizing & improving processes (manufacturing 4.0 technologies).
• Able to communicate in English.
• Strong verbal and written communication and presentation skills.
• Familiarity with the requirements of GAMP 5 and other key Medical Device industry standards/regulations including FDA 21 CFR Part 11, FDA CFR Part 820, ISO 14971, ISO 13485, ISO 9001, and EU MDR.
• Knowledge of crucial manufacturing metrics and key performance indicators.

The anticipated base compensation range for this position is $115,000.00 - $158,125.00 USD annually. The actual base pay offered to the successful candidate will be based on multiple factors, including but not limited to job-related knowledge/skills, experience, geographical location, and internal equity. It is not typical for an individual to be hired at the high end of the range for their role at Smith + Nephew. Compensation decisions are dependent upon the facts and circumstances of each position and candidate.

To be considered for this role, please submit your application by April 15, 2025

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.