Staff Engineer, Automation

Summary:

This position is responsible to deliver cost savings through the design, implementation, and commissioning of automation projects across the Smith + Nephew manufacturing network. The successful candidate will have a track record of specification, development, characterization, launch, and support of reliable, robust and efficient manufacturing for operational excellence.

The Staff Automation Engineer works with internal multi-functional teams, external equipment builders and contract manufacturers in the successful development of various manufacturing systems. This position is responsible through scale-up of automation projects ensuring that schedule, cost, delivery, and quality requirements are met.
Duties and Responsibilities:

• Lead all aspects of multiple automation projects in multiple locations including Smith + Nephew locations and automation integrators. You will establish and lead project plans and budgets for these projects ensuring manufacturing requirements, cost, quality, return on investment, and timing expectations are met.
• Find opportunities for savings and develop project proposals and capital expense requests that accurately predict costs, return on investment, and schedule for major programs.
• Properly identify and prioritize key strategic programs and weigh alternatives for project execution, using in-house and third-party resources.
• Design and/or coordinate manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining, and material handling.
• Design and arrange machines within plant facilities to ensure most efficient and productive layout.
• Adapt machine or equipment design to factory and production conditions.
• Lead inspection and test requirements as required by the project.
• Inspect the performance of machinery, equipment, and tools to verify their efficiency
• Investigate and initiate corrective action for problems and deficiencies to ensure product quality.
• Develop manufacturing processes that are applicable to statistical process control.
• Provide mentorship to engineering teams regarding design concepts and specification requirements to best use equipment and manufacturing techniques.
• Develop the writing of User Requirement Specifications & Statements of Work including and low-level technical specifications for large scale projects. You will have
• Demonstrated proficiency in translating user needs into functional requirements and physical implementations that accurately reflect customer need.
• Ensure processes and procedures are in compliance with regulations.
• Drive independently through challenges to deliver on commitments and drive several projects simultaneously.
• Communicate clearly in verbal, written, and graphical formats.
• Have an in-depth understanding of Medical standards such as FDA 21 CFR Part 11, FDA CFR Part 820, ISO 14971, ISO 13485, ISO 9001, CMDCAS/CMDR. You will understand medical device requirements for software validation, Installation Qualification (IQ), Operation Qualification (OQ) and Process Qualification (PQ) as they relate to production equipment validation.
• Understand safety standards and guarding techniques for automation systems that conform to appropriate industry regulations
• Coordinate or drive equipment, process and software qualifications.
• Possess deep technical knowledge of Programmable Logic Control (PLC), manufacturing robotics, and machine design
• Demonstrate a passion for driving innovation and delivering results that serve patient and business need. You will be able to passionately advocate and advise on emerging technologies in automation.

Must-Have:

• Bachelor's Degree in Science or Engineering and 10 years professional work experience in manufacturing automation OR Advanced Degree in Science or Engineering with 8 years professional work experience in automation
• Demonstrated experience in the design and delivery of large scale (greater than $500,000) manufacturing automation projects incorporating material handling, machining, sensing, and data connectivity
• Demonstrated experience in assessing automation opportunities including developing project proposals, schedules, and financial assessments.
• A demonstrated track record of on-time on-budget delivery of automation projects and an understanding of your customers' needs

Nice to Have:

• Experience with software automation tools & PLCs (e.g., Allen Bradly, Rockwell Automation, etc)
• Experience with Manufacturing 4.0 / Industrial Internet of Things (IIOT) technologies
• Strongly prefer FDA experience in either direct role in medical device/biopharma or consulting work on medical device/biopharma project
• Knowledgeable in the understanding and development of software validation plan and reports
• Experience in applying Good Automated Manufacturing Practices to machine design
• Experience in legacy PLC platforms
• Experience in developing equipment for use in a clean room environment.
• Solid understanding of machining, tool, and Gage design, Gage R&R and Geometric Dimensioning and Tolerancing.
• Ability to build and/or update design files and drawings in SolidWorks.
• Spanish language skills a plus

Job Requirements:

• While performing the duties of this job, the employee is regularly required to be independently mobile.
• The employee is also required to interact with a computer, and to communicate with peers and co-workers.
• As the team is international, this position may involve occasional or periodic conference calls outside of US business hours
• Able to lift 25 pounds
• Extended periods of time doing computer-based work
• Position may require up to 20% travel.

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.