Engineer I - Advanced Manufacturing (Electrical)- Ave Maria, FL. (Finance)

Requisition ID: 63054 Title: Engineer I - Advanced Manufacturing (Electrical)- Ave Maria, FL. Division: Arthrex Manufacturing Inc (US02) Location: Ave Maria, FL.

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is currently seeking an Advanced Manufacturing Engineer- Electrical, to provide process engineering support to AMI Packaging Operations (Ex. Laser Mark/Weld, Passivation, Cleaning, Device Assembly, Packaging, Boxing) and INC Product Design teams to achieve business goals. To lead the electrical design and programming of custom semi-automated or fully automated manufacturing equipment, tooling and fixturing. To implement electrical hardware and software/programming solutions to improve safety, quality, and efficiency of manufacturing processes. To implement solutions to improve data collection and analytics of manufacturing equipment. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™, located at our Ave Maria, FL manufacturing site.

Monday- Friday, (8:00AM-5:00PM)

Essential Duties and Responsibilities:

• Support a customer-focused culture by identifying key customer/user requirements and translating those into functional and design specifications during the design of custom equipment and fixturing.
• Support a continuous improvement culture to enhance safety, quality, delivery, and cost by employing Lean/Six Sigma continuous improvement tools in all projects.
• Support a highly innovative culture by identifying novel/first-of-a-kind solutions, and applying lessons learned through successes and failures.
• Support a fast-paced, accountable, teamwork culture by completing project tasks on-time, identifying potential roadblocks, and effectively communicating status escalating issues.
• Support new product development, design transfer, and continuous improvement (Kaizen) projects as the subject matter expert for equipment electrical controls and programming.
• Maintain compliance with Safety requirements related to equipment access controls, electronic safety features, and interlocks.
• Maintain compliance with Medical Device Quality System requirements related to equipment and software validation (CSV).
• Design and develop electrical/controls solutions for custom automation or semi-automated equipment or fixturing.
• Design and develop custom electrical/functional testing systems for electro-mechanical medical devices.
• Identify and evaluate the optimum electrical controls and software solutions based on the latest available technology and industry best practices.
• Develop capital equipment project scope, budget, milestones, and follow a structured Management of Change process.
• Provide requirements to equipment vendors (OEMs) and review design and specification packages during equipment quotation.
• Create and execute validation protocols and reports compliant with Medial Device requirements (IQ, OQ, PQ) .
• Create Equipment maintenance manuals, recommend Preventive Maintenance Plans, and spare parts .
• Create operator work instructions and troubleshooting guides .
• Lead Root Cause Investigations or equipment troubleshooting using structured problem-solving tools (Lean A3, Six Sigma DMAIC) and Statistical Analysis.
• Lead process development or process improvement work using process Failure Mode Analysis (pFMEA) and structured Design of Experiments (DOE's)
• Ensure data and documentation are consistently accurate and complete and in compliance with Good Documentation Practices (GDP).
• May supervise Technician, Engineering, Prototype or Programming personnel.

Education/ Experience:

• B.S. in Engineering required, preferably in Mechanical, Electrical, Chemical, or Computer Engineering.
• Engineering Co-Op or internship experience preferred.
• Experience in medical device manufacturing or other health sciences industry preferred.
• SAP, miniTab, Solidworks experience preferred.

Skills:

• Basic knowledge of Materials and Machine design/function.
• Basic understanding of select manufacturing processes.
• Basic knowledge of Industry Standard (ASTM) Test Methods
• Basic knowledge of using CAD and MS Office Suite software.
• Basic knowledge of SPC (Statistical Process Control).
• Basic knowledge of programming fundamentals. PLC, Audino or Raspberry Pi experience preferred.
• Ability to modify PLC/HMI programs to address issues and enhance functionality of existing equipment.
• Basic knowledge of AC/DC electrical controls.
• Ability to execute process validations, analyze data, and write reports.
• Ability to draft and execute engineering study protocols, analyze data, and write reports.
• Detail oriented with strong analytical and communication skills.

Knowledge:

Limited use and/or application of basic principles, theories, and concepts.

Limited knowledge of industry practices and standards.

Reasoning Ability:

Solves routine problems of limited scope and complexity following established policies and procedures.

Discretion/ Latitude:

Work is closely supervised. Follows specific, detailed instructions.

Reasoning Ability:

Ability to define problems, collects data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Mathematical Skills:

Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements.

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 stand for 8-10 hours per day wearing gowns, hairnets, and gloves; use hands and fingers, to handle, or feel; and reach with hands and arms. The employee must frequently lift and/or move up to 20 pounds. Must possess the dexterity to utilize writing utensils (pen/pencil), calculators, small hand-held tools, manual razors, and other mechanical/electrical equipment without assistance. Ability to work in close proximity to fellow teammates in cramped conditions.

Vision Requirements:

Visual acuity necessary to do the job safely and effectively.

Specific vision abilities required by this job include close vision using a microscope and light source

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.