Packaging Engineer II- Ave Maria, FL. at Arthrex Manufacturing, Inc. in Ave Maria, Florida

Job Description:

Requisition ID: 60622 Title: Packaging Engineer II- 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 Manufacturing is currently seeking a Packaging Engineer II. The Engineering II will provide packaging engineering support for design engineering projects. Support and assist packaging engineering development goals in support of overall business goals. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

Hours - Monday- Friday, 8:00am - 5:00pm

Essential Duties and Responsibilities:

Coordinate Packaging Development activities for new MPI's and product improvement projects. This may include but is not limited to the following:

• Create and maintain packaging engineering specifications utilizing CAD, 3D modeling software, or other software tools.


• Create and maintain packaging designs for sterile and non-sterile products.


• Select appropriate packaging materials based on product and sterilization requirements.


• Create and maintain Packaging Instruction documents for the final manufacturing packaging assembly of finished devices.


• Communicate (not execute) packaging process validation activities with manufacturing or designated design team member for Arthrex products.


• Coordinate and execute packaging design validation activities post packaging process approval.


• Oversee any required package testing to assure viability of packaging/product construct for sterile and non-sterile barrier protection.


• Generating protocols, test reports, and engineering adoptions and maintenance of test documentation per approved documentation system per quality standards.


• Ensure essential packaging development activities are completed prior to packaging design transfer activities.

Coordinate Instrument Case development activities for new MPI's and product improvement projects. This may include but is not limited to the following:

• Coordinate and Create Instrument Case Layouts with Design Team and Contract Suppliers.


• Create and maintain Instrument Case Specifications.


• Oversee Design Verification and Validation activities for Instrument Cases.


• Lead Instrument Case project when Instrument Case is a standalone MPI.

• Provide support for packaging engineering related CAPA's.


• Provide supporting packaging documentation to Regulatory and Quality for 510(k) and ERC submissions and audits.


• Create Bill of Materials and generate Engineering Change Orders (ECO) in support of new products and various revisions or maintenance.


• Communicate effectively with Design Team members and Contract Suppliers using project management tools, written, and verbal communication.


• Support product design changes to develop and improve existing products that affect existing packaging.


• Oversee any required package testing to assure viability of packaging/product construct and sterile barrier protection. This includes


• Provide supporting packaging documentation to Regulatory and Quality for 510(k) and ERC submissions and audits.


• Create Bill of Materials and generate Engineering Change Orders (ECO) in support of new products and various revisions or maintenance.


• Communicate effectively with Design Teams and Contract Suppliers using project management tools, written, and verbal communication.

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.

Skills

• Proficiency in Packaging Design Development requirements as required by quality and regulatory standards.


• Proficiency in using CAD software for designing, creating, and maintaining sterile and non-sterile packaging components.


• Proficiency in creating packaging specifications for sterile and non-sterile components.


• Proficiency in creating packaging components and specifications for sterile and non-sterile packaging components.


• Proficient at writing and creating Packaging Instructions for non-sterile and sterile packaging assemblies.


• Proficient at writing protocols, test reports, and adoptions for packaging engineering studies.


• Basic Knowledge of ISO 11607, ISTA, and ASTM Test standards associated with Medical Device Packaging.


• Proficient knowledge of packaging validation test standards and equipment.


• Proficient knowledge of design, manufacturing, and inspection methods and processes.


• Proficient at developing engineering specifications and drawing conventions that align with Engineering and Quality standards.

Education/ Experience

• B.S. in Engineering required; preferably in Packaging Engineering


• Minimum of 2 Yrs. experience in Packaging Design and Development or Manufacturing required


• Medical device packaging or manufacturing environment experience preferred

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 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.

Vision Requirements:

Visual acuity necessary to do the job safely and effectively.

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 2024 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 or protected veteran status.

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