Job Description

Requisition ID: 64546 Title: Engineer I - Packaging Division: Arthrex, Inc. (US01) Location:
Naples, FL

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for an Engineer I – Packaging. This individual will be responsible for providing packaging engineering support for design engineering projects, as well as support and assist packaging engineering development goals in support of overall business goals. The successful candidate would have a proven track record in packaging engineering, with expertise in developing and validating packaging solutions for sterile and non-sterile medical devices. They should demonstrate strong proficiency in CAD and 3D modeling tools, knowledge of material selection for sterilization requirements, and experience coordinating design verification and validation activities. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

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.

Education/Experience:

• Bachelor's degree in Engineering required; preferably in Packaging Engineering.
• Experience in medical device packaging or manufacturing preferred.
• Packaging internship or work experience in electronic drafting or technical functions preferred.

Knowledge:

• Limited use and/or application of basic principles, theories, and concepts. Limited knowledge of industry practices and standards.

Skills:

• Basic knowledge of Packaging Design Development requirements as required by quality and regulatory standards.
• Basic knowledge using CAD software for viewing, creating, and maintaining non-sterile and sterile packaging components.
• Basic skills to create packaging specifications for sterile and non-sterile packaging components.
• Ability to develop and write Packaging Instructions for non-sterile and sterile packaging assemblies.
• Ability to write protocols, test reports, and adoptions related to packaging validation.
• Ability to oversee the execution of packaging engineering studies.
• Able to read and understand engineering specifications and drawing conventions.

Incidental Duties:

• The above statements describe the general nature and level of work being performed in this job. They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management.

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.

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.