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Engineer II

4 months ago

Naples, United States Arthrex Full time
Requisition ID: 58877 Title: Engineer II - 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 a Packaging Engineer II who will provide packaging engineering support for design engineering projects. They will support and assist packaging engineering development goals in support of overall business goals. Excellent interpersonal, computer and analytical skills with a Bachelor's degree in Engineering and two years or more of post graduate experience in Packaging Design and Development or Packaging Manufacturing will be essential for this position. Experience in medical device industry is highly desired. This position could be located at our corporate campus in Naples, FL or Pendleton, SC manufacturing campus. 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 of Science in Engineering required; preferably in Packaging Engineering.
  • Minimum of 2 years' experience in Packaging Design and Development or Manufacturing required.
  • Medical device packaging or manufacturing environment experience preferred.
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.
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.

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.