Arthrex Manufacturing - Corkscrew, FL

posted 3 months ago

Full-time - Mid Level
Corkscrew, FL
Miscellaneous Manufacturing

About the position

Arthrex, Inc. is a global leader in medical device development and education in orthopedics, and we are currently seeking a Sr. Automation Engineer specializing in Robotics, Vision Systems, and Controls for our Ave Maria, FL facility. This role is pivotal in establishing and maintaining standards for technology and equipment within our manufacturing operations. The ideal candidate will possess a Bachelor's Degree in Engineering, preferably with a focus on Automation, and have a minimum of 5 years of relevant post-graduate manufacturing experience. The Sr. Automation Engineer will work closely with engineering and operations teams to provide expertise in automation technologies, ensuring that our processes are efficient, safe, and ergonomic. In this position, the engineer will be responsible for programming new equipment and developing solutions that can be deployed in manufacturing environments. This includes establishing governance for technology, creating and maintaining programming, hardware, and software standards, and developing training standards for engineering and technical staff. The engineer will also maintain a portfolio of scalable solutions that support process improvements and will participate in gathering user and customer functional requirements. Familiarity with machine protocols such as MTConnect, OPC UA, Modbus, MQTT, and TCP/IP is essential. The role requires analyzing business processes for potential improvements, developing Automation Design Specifications, and ensuring compliance with regulations such as ISO CFR 21 Part 11 and cGMP. The engineer will also be involved in software and hardware architectural design, lead automation solution development, and mentor junior engineers. Excellent communication skills are necessary to collaborate effectively with both technical and non-technical team members. The position may require travel up to 25%.

Responsibilities

  • Provide technical consulting to operations and engineering teams.
  • Program new equipment and build solutions for manufacturing spaces.
  • Establish, maintain, and enforce governance of technology.
  • Create and maintain programming, hardware, and software standards.
  • Develop and support training standards for engineering and technical staff.
  • Maintain a portfolio of solutions for scalable deployments that support process, safety, and ergonomic improvements.
  • Participate in gathering user/customer functional requirements.
  • Analyze business process potentials for streamlining and improvements in efficiencies.
  • Develop Automation Design Specifications, Test and Acceptance Plans, Software testing and code review.
  • Provide and support process validation procedures and execution.
  • Ensure validations are compliant with appropriate regulations, such as ISO CFR 21 Part 11, 820 and cGMP regulations, and corporate policy.
  • Develop/estimate project schedules/tasks based on requirements.
  • Program using a variety of languages for controlling and monitoring manufacturing and inspection equipment.
  • Assess the impact of system changes through change management and change control systems and develop risk mitigation and contingency plans.
  • Lead design for all aspects of automation solution development and architecture to provide value to customers.
  • Monitor equipment for abnormalities and propose areas for improvement regarding availability and speed of the applications.
  • Collaborate with other engineering and technical teams to establish best practices and patterns that support high quality, reliable solutions.

Requirements

  • Bachelor's Degree in Engineering, preferably in Automation.
  • 5 years of experience in operations, engineering, or automation.
  • Experience working in an FDA regulated environment preferred.
  • Advanced knowledge of materials and relevant machine design/function.
  • Advanced understanding of all relevant manufacturing processes and interdependencies.
  • Ability to draft process validation protocols, execute, analyze data, and write reports.
  • Proficiency in Industry Standard (ASTM) Test Methods.
  • Proficiency in drafting and executing complex engineering study protocols, Design of Experiments (DOE's), analyzing data, managing deviations and writing reports.
  • Ability to use project management tools to plan projects.
  • Ability to prepare a capital equipment budget and justification (ROI).
  • Advanced knowledge in systems and controls programming and integration.
  • Advanced CAD software skills required.

Nice-to-haves

  • Experience in building APIs for both internal and external products.
  • Familiarity with machine protocols such as MTConnect, OPC UA, Modbus, MQTT, TCP/IP.

Benefits

  • Medical, Dental and Vision Insurance
  • Company-Provided Life Insurance
  • Voluntary Life Insurance
  • Flexible Spending Account (FSA)
  • Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)
  • Matching 401(k) Retirement Plan
  • Annual Bonus
  • Wellness Incentive Program
  • Free Onsite Medical Clinics
  • Free Onsite Lunch
  • Tuition Reimbursement Program
  • Trip of a Lifetime
  • Paid Parental Leave
  • Paid Time Off
  • Volunteer PTO
  • Employee Assistance Provider (EAP)
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