About The Position

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for a Senior Engineer II – Automation & SCADA for our Ave Maria, FL facility, who will lead a team of Operations Technology members in architecting, designing, and maintaining the methods of utilizing plant floor data to drive business improvements. Responsibilities will include ensuring platform security, reliability, and developing expertise in the Industry 4.0 space. The successful candidate will understand the technologies available and where industry trends are driving digitization and data driven decision making. The team is accountable for maintaining a robust environment for all operational departments and ensuring trust in data. Will partner with engineering teams focused on process improvement and automation capability to collaborate and under Technical Operations leadership help drive strategic digital transformation activities that add business value. Another necessary value is to establish and maintain standards for technology and equipment as well as leading a team of direct reports. Must have a bachelor’s degree, preferably in Engineering with an emphasis on Automation and SCADA platforms. Having at least 8 years of relevant post graduate manufacturing experience is preferred. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™. Operations Technology Engineers provide expertise to engineering and operations teams across Arthrex Manufacturing in the areas of Automation, Robotics, Vision Systems, ARVs/AGVs. Governance Standards and Training Programming Solutions portfolio

Requirements

  • Bachelor’s Degree required preferably in an engineering field with emphasis on automation.
  • 8 years of experience in operations, engineering, or automation required.
  • 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.
  • Ability to keep informed on emerging technologies and recommends process improvements accordingly.
  • Proficiency in preparing complex capital equipment proposals including cost analysis and justification (ROI).
  • Proficiency in new or custom equipment design.
  • Ability to proactively communicate ideas, results, recommendations, and status effectively in oral and written forms.
  • Ability to supervise technicians, contractors, and junior level engineers directly and effectively.
  • Ability to innovate new design solutions to modify existing equipment or design new, fully custom equipment.
  • Ability to communicate ideas, results, recommendations, and status effectively in oral and written forms.
  • Ability to coach & mentor junior level engineers and technicians.
  • Ability to create and maintain accurate pFEMAs for assigned processes.
  • Ability to apply structured problem-solving techniques and develop process design solutions to improve existing manufacturing and/or testing methods.
  • Advanced CAD software skills required.

Nice To Haves

  • Experience working in an FDA regulated environment preferred.

Responsibilities

  • Responsible for providing technical consulting to operations and engineering teams.
  • Programming new equipment and building solutions that can be deployed in 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.
  • Participates in gathering user/customer functional requirements.
  • Familiar with machine protocols MTConnect, OPC UA, Modbus, MQTT, TCP/IP, and other similar protocols.
  • 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.
  • Maintain current with ISO/FDA and internal quality assurance policies.
  • Develop/estimate project schedules/tasks based on requirements.
  • Programming using a variety of languages for controlling and monitoring manufacturing and inspection equipment.
  • Assess the impact of system changes thru change management and change control systems and develop risk mitigation and contingency plans.
  • Software and hardware architectural design for the manufacturing and inspection equipment
  • Frequent use and general knowledge of industry practices, techniques, and standards. General application of concepts and principles.
  • Lead design for all aspects of automation solution development and architecture to provide value to customers, where applicable.
  • Demonstrate excellent communication skills with technical and non-technical teammates and show a high level of professionalism.
  • Work effectively with all members of a cross functional software development team.
  • Mentorship of lower-level engineers.
  • Experience in building APIs for both internal and external products.
  • Monitor equipment for abnormalities and propose areas for improvement regarding availability and speed of the applications.
  • Collaborate with other engineer and technical teams to establish best practices and patterns that support high quality, reliable solutions.
  • Able to travel up to 25%.
  • Complete understanding and application of principles, concepts, practices, and standards. Full knowledge of industry practices.
  • Lead large technology initiatives.
  • Mentor other engineers and technical resources.
  • Act as a consultant for solution and implementation challenges.
  • Provide technical expertise and leadership within related areas of the organization.
  • Guide colleagues in mentoring others and improving processes and toolsets.
  • Prioritize requests and needs with team and department roadmaps.
  • Deconstruct problems into an executable action plan for themselves and other engineers.
  • Delegate tasks to other developers on the team, and ensure tasks and features are completed in a timely manner.
  • Continuously challenge current software state to propose improvements.

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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