Sr Engineer - Packaging

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 Senior Engineer I – Packaging. This role will provide packaging engineering support for design engineering projects, as well as support and assist packaging engineering development goals in support of overall business goals. Our ideal candidate would have advanced expertise in designing complex packaging and instructions using CAD tools (AutoCAD or Solid Works), and strong leadership in DHF projects for packaging and instrument cases.

They possess deep knowledge of packaging validation processes aligned with quality and regulatory standards, and excel at researching innovative materials and suppliers for cost and process improvements. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

• 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.

• B.S. in Engineering required; preferably in Packaging Engineering.
• Minimum of 5 years of experience in Packaging Design and Development or Manufacturing required.
• Medical device packaging or manufacturing environment experience preferred.

• Advanced capabilities in designing complex packaging designs and packaging instructions using a CAD program (AutoCAD or Solidworks) required.
• Proficient at leading DHF projects for Packaging only and Instrument Case projects.
• Advanced knowledge of packaging validation process…