Arthrex, Inc. is a global medical device company and a leader in new product development and medical education. We are a privately held company that strives to accomplish our corporate mission of Helping Surgeons Treat Their Patients Better™. We are committed to delivering uncompromising quality to the health care professionals who use our products, and ultimately, the millions of patients whose lives we impact.
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 Lunch
Tuition Reimbursement Program
Trip of a Lifetime
Paid Parental Leave
Paid Time Off
Volunteer PTO
Employee Assistance Provider (EAP)
Please note, most benefits are for regular, full time employees.
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.
Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex Manufacturing, Ave Maria, FL. Location is actively searching for a Packaging Lean Operations Engineer Technician to provide technical support to AMI Packaging Engineering, Packaging Operations, Manufacturing Engineering, and INC Packaging and Design Engineering. To support projects involving: commercialization of new products; improvements in product and process performance; increases in productivity; and reduction of costs. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.
Hours - Monday-Friday, 8:00 am – 5:00 pm
Essential Duties and Responsibilities:
- Supports new product development by assisting with Packaging Design validations and Process/Equipment validations in the Laser, Passivation, Cleaning, Assembly, Packaging, Boxing, and 2nd Pack areas.
- Develops sampling and testing plans under the direction of the area process/manufacturing engineers to support Engineering Studies and Validation protocols.
- Supports department Process Engineers in drafting and executing validation protocols and reports (DOE/IQ/OQ/PQ) for the following processes: laser-marking, passivation, cleaning, manual and automated assembly, pouch sealing, blister sealing, and automated assembly processes.
- Supports department Process Engineers in drafting work instructions.
- Supports department Process Engineers with designing, procuring, assembling new tools and fixtures used in production.
- Ensures tool and fixture drawing documentation is created/revised according to governing procedures.
- Supports the design and maintenance of tools and fixtures: Supports Production in the control, repair tracking, and inventory of tools and fixtures. Requests quotes as needed for new tool/fixtures and/or for repairs.
- Supports the Calibration department by identifying and locating process equipment and test instruments that require calibration.
- Supports the Product engineers during new product and/or packaging introductions into the Packaging Department (Laser, Passivation, Cleaning, Clean Rooms, Boxing, 2nd Pack).
- Maintains precise identification and control of validation samples and ensures information and documentation is consistently accurate.
- Remains current with ISO/FDA/STM standards and internal quality assurance policies.
- Performs production equipment setups and troubleshooting where required.
- Verifies and documents machine settings and test results where required.
- Performs time studies and collects data to support continuous improvement activities.
Education/Experience:
- High School Diploma or equivalent required.
- 2 years Manufacturing experience or other technical professional work (ASE, HVAC) required.
- Ability to understand Drawings, Blueprints, BOM’s, Routings, Validation Protocols, and DHR’s preferred.
- Lean Manufacturing experience is preferred.
- Experience with computerized ERP and PLM systems (Oracle, SAP, Agile, etc.) preferred.
Skills
- Basic knowledge of MS Office programs required.
- Basic ability to navigate SAP, Documentum, and Agile required.
- Basic ability to understand engineering specifications and drawing conventions.
- Basic knowledge of component manufacturing, product assembly, visual inspection, packaging processes, and labeling requirements.
- Knowledge of raw materials, inventory traceability, production processes, barcode scanning and labeling controls, inspection methods and equipment, and other techniques for maximizing the effective manufacturing and distribution of goods.
- Ability to execute Engineering Study protocols and document results supporting Validations.
- Knowledge of Packaging Testing Equipment. Able to assist sample preparation and testing (if supporting the Packaging/Sealers).
- Knowledge of Process area equipment for the area supported (eg. Packaging-sealers, automation equipment, laser-markers, passivation, cleaning).
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.
