Engineer I - Packaging

Arthrex•Pelican Bay, FL

About The Position

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™.

Requirements

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.
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.

Responsibilities

Coordinate Packaging Development activities for new MPI’s and product improvement projects.
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.
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.
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.