Senior Engineering Tech- (Packaging)- Ave Maria, FL. - Arthrex

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 is currently seeking a Senior Packaging Engineer Tech 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™.

If hired for this position, you will be eligible for a $750.00 sign-on bonus (minus appropriate tax withholdings) which will be paid in your first pay period.

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.  A 2 year Associates Degree in a Math, Science, Technical or Engineering discipline preferred.
• Minimum of 5 Yrs. experience as an Engineering Technician or 5 years Manufacturing experience related to medical device manufacturing required or combination of college and direct experience required.
• Understanding of Drawings, Blueprints, BOM’s, Routings, Basic Statistics, Validations, and DHR’s required.
• Lean Manufacturing experience is strongly preferred.
• Experience with tool management and inventory systems required (Guhring, Matrix, etc.) required.
• Experience with computerized ERP and PLM systems preferred (Oracle, SAP, Agile, etc.) required.
• Expertise with Microsoft Office and CAD products required.

Knowledge:

Complete understanding and application of principles, concepts, practices, and standards.  Full knowledge of industry practices.

Reasoning Ability:

Develops solutions to a variety of complex problems.  May refer to established precedents and policies.

Discretion/ Latitude:

• Work is performed under general direction. 
• Participates in determining objectives of assignment. 
• Plans, schedules, and arranges own activities in accomplishing objectives. 
• Work is reviewed upon completion for adequacy in meeting objectives. 

Skills: 

• Proficiency of MS Office programs required.
• Ability to navigate SAP, Documentum, and Agile required.
• Ability to open and view drawing specifications using a CAD program.
• A thorough knowledge of component manufacturing, product assembly, visual inspection, packaging processes, and labeling requirements.
• Ability to understand engineering specifications and drawing conventions.
• Proficiency in creating tooling/fixturing drawings using a CAD program.
• Proficiency in creating and revising work instructions utilizing Microsoft Word and a Document Management System.
• Ability to write Engineering Study protocols and final reports supporting Validations.
• Ability to perform basic statistical analysis of experimental data using Statistical software (MiniTab).
• Knowledge of ISO 11607, ISTA, and ASTM Test standards associated with Medical Device Packaging (if supporting the Packaging/Sealing area).
• Knowledge if ASTM methods applicable to Laser-Marking, Passivation or Cleaning (if supporting those areas)
• Ability to set up and operate all Packaging Test Equipment per internal Work Instructions (if supporting that area).
• Ability to program and set up, operate Laser-Marking Equipment (if supporting that area)
• Ability to set up and operate Passivation and Cleaning equipment (if supporting that area)
• Expected to train and assess operators and other trainers on when competency training is required..
• Knowledge of Raspberry Pi systems if supporting an area that uses these systems (Cleaning, Packaging).
• Exposure to Lean/Continuous Improvement methods (Root Cause Analysis, A3, Kaizen)

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.