Arthrex Manufacturing in Ave Maria, FL is looking for an Engineer II for the Operations Technology department, this includes design, develop, implement and improve manufacturing processes to produce cost effective quality medical device products and systems.  Provide manufacturing engineering expertise to create, document and implement required procedures and documents.

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

Essential Duties and 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
• Other duties as assigned.
• Able to travel up to 25%.

Additional Duties & Responsibilities:

All from Essential Duties & Responsibilities, plus…

• Contribute to all aspects of automation solution concept, design, development, testing, implementation, and support.
• Limited use and/or application of basic principles, theories, and concepts.
• Limited knowledge of industry practices and standards.
• Participate in automation and related architecture design activities.
• Share on-call duties.
• Conduct technology reviews, provides feedback, and suggests changes as needed.
• Conduct analysis and identify areas for continuous improvement.
• Review technology functionality and updates and identify new features that can be enabled for the business, where applicable.
• Improve performance of existing hardware and solutions by diagnosing and resolving issues and implementing enhancements.
• Participate in the improvement of automation standards.
• Write high-quality code that satisfies customer needs and strives for simplicity, clarity, and testability.
• Conduct stakeholder presentations.

Education/Experience:

• Bachelor’s Degree required preferably in an engineering field with emphasis on automation.
• 2 years of experience in operations, engineering, or automation.
• FDA regulated environment preferred.

Machine, Tools, and/or Equipment Skills:

PC servers, workstations and laptops.  Microsoft environment. Work with standard current computer applications, word processing, spreadsheets, enterprise applications such as ERP, MES, PLM and CRM.

Language and Communication Skills:

Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above.  Ability to verbally communicate ideas and issues effectively to other team members and management. Ability to write and record data and information as required by procedures.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  While performing the duties of this job, the employee is regularly required to talk or hear.  The employee is frequently required to sit; use hands and fingers, to handle, or feel; and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  The area that this job is performed in is a general office or open cubicle/workstation environment.  The noise level in the work environment is usually moderate.

Arthrex 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)

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by law.