Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics.  Arthrex is currently seeking a Manufacturing Process Engineer II, to provide process engineering support to AMI Packaging Operations (Ex. Laser Mark/Weld, Passivation, Cleaning, Component/Device Assembly, Packaging, Boxing) and INC Product Design teams to achieve business goals.  To lead projects involving: rapid commercialization of new products; commercialization of new laser, passivation, cleaning, assembly, and mechanized equipment; improvements to equipment; data collection; process performance improvements; increases in productivity and production capacity; and ongoing reduction of costs. 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.

First Shift – 8am- 5:00pm- Monday- Friday

Essential Duties and Responsibilities:

• Support new product development/design transfer by leading process development and validation. 
• Develop and support a continuous improvement culture to enhance quality, operational excellence, and cost.
• Develop and maintain Master Validation Strategies and Master Validation Plans for component manufacturing, device assembly, packaging, data collection, and process efficiency.
• Draft and execute validation protocols and reports (IQ,OQ/PQ) for manual assembly and mechanized processes.
• Lead the design, development, and commercialization of new equipment including gathering user requirements, designing equipment mechanical and electrical systems, developing equipment specifications, coordinating quotes and procurement of new equipment with vendors, validation, work instruction development, BOM and Router management, and training of operations.
• Confers with vendors to determine product specifications and arrange for purchase of equipment, materials, or parts, and evaluates products according to specifications and quality standards.
• Design, develop, and manage tooling and fixtures.  Coordinate quotes and procurement of new tooling with vendors.  Assess and execute validation requirements accordingly.
• Support the maintenance of equipment and tooling once released to production through troubleshooting, repair tracking, and analysis of impact to the validated state.
• Introduce and support new equipment, products, and processes utilizing industry standard project management tools and techniques.
• Develop an understanding of current manufacturing processes and identify targets for improvement in data collection/trending, work order transaction processes, and operational efficiencies.
• Lead process improvement projects through Designed Experiments (DOE’s), structured problem solving (Lean A3, Six Sigma DMAIC), and Statistical Analysis.
• Ensure data and documentation are consistently accurate and complete.
• Applies statistical methods to estimate future manufacturing requirements and potential.
• Analyzes and plans workforce utilization, space requirements, and workflow, and designs layout of equipment and workspace for maximum efficiency utilizing lean techniques when feasible.
• Estimates production times, staffing requirements, and related costs to provide information for management decisions.
• Develop sampling procedures, forms, and instructions for recording, evaluating, and reporting quality and reliability data.
• Remain current with ISO/FDA/ASTM standards and internal quality assurance policies.  Support Audits as the process subject matter expert.
• May supervise Technician, Engineering, Prototype or Programming personnel.

Education/Experience:

• B.S. in Engineering required; preferably in Mechanical, Electrical, Chemical, or Computer Engineering
• Minimum of 2 Yrs. experience in Design and Development or Manufacturing Engineering required.
• Experience in medical device manufacturing or other health sciences industry preferred.
• SAP, miniTab, Solidworks experience preferred.

Skills:

• Proficiency in Materials and relevant Machine design/function.
• Basic understanding of all relevant manufacturing processes.
• Proficiency in Industry Standard (ASTM) Test Methods.
• Basic knowledge of ISO 13485 and FDA 21 CFR Part 820 as related to cGMP and Process Validations.
• Intermediate CAD software skills for viewing, creating, and maintaining (mechanical and/or electrical) drawings.
• Ability to create simple PLC programs (specific to automation roles only)
• Ability to draft process validation protocols, execute, analyze data, and write reports.
• Proficiency in drafting and executing technical documentation, engineering study protocols, analyzing data, and writing reports.
• Ability to communicate ideas, results, recommendations, and status effectively in oral and written forms.
• Ability to apply SPC (Statistical Process Control) practices to validations.
• Familiarity with clean room practices preferred.
• Project management experience preferred.

Knowledge:

Frequent use and general knowledge of industry practices, techniques, and standards.  General application of concepts and principles.

Reasoning Ability:

Develops solutions to a variety of problems of moderate scope and complexity.  Refers to policies and practices for guidance.

Discretion/ Latitude:

Works under general supervision.  Work is reviewed for soundness of judgment and overall adequacy and accuracy. 

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.