Senior Operational Technology Engineer

Job Summary:

Smith+Nephew is looking for a Senior Operational Technology (OT) Engineer to join our Global OT team. This position location is flexible, and may be in either Massachusetts or Memphis, Tennessee.

You will be responsible for identifying, implementing, and supporting 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.

The Senior OT Engineer is responsible for working 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. This position is responsible for ensuring that timeline landmark commitments are achieved while meeting all Safety, Quality, and Cost requirements and for achieving performance targets for efficiency savings and value.

Essential Duties/Responsibilities:

• 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 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 sophisticated 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 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.

Location:

• Flexible: Mansfield, MA; Andover, MA; Memphis, TN

Education:

• Bachelor's Degree in Science or Engineering

Experience:

• 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 projects
• Understand medical device requirements for software validation, Installation Qualification (IQ), Operation Qualification (OQ) and Process Qualification (PQ) as it relates to production equipment validation.
• Working 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)

Competencies:

• Able to communicate effectively 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
• Understanding of key manufacturing metrics and KPI's

Physical Demands:

• Regularly required to be independently mobile.
• Interact with a computer and connect with peers and co-workers.
• Able to lift 25 pounds.

Travel Requirements:

• 10-25%

Comments:

This job description is an outline of the major recurring responsibilities of the job and is not intended to be all-inclusive of the work to be performed. The incumbent(s) will typically perform other related job objectives and special assignments.

About Us:

Smith+Nephew is a global medical technology company. We design and manufacture technology that takes the limits off living! We support healthcare professionals to return their patients to health and mobility, helping them to perform at their fullest potential!

Care, Collaboration, & Courage:

Care means that we show empathy and understanding for each other, our customers, and patients.

Collaboration means we work together as a team, based on mutual trust and respect.

Courage is about continuous learning, innovation, and accountability.

Veterans are strongly encouraged to apply.

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.