Engineer, Sr. I - Packaging

Arthrex•Pelican Bay, FL

31d

About The Position

Arthrex is seeking a Sr. Engineer I - Packaging to provide packaging engineering support for design engineering projects and advance packaging engineering development goals in support of business objectives. The role coordinates packaging development for new products and product improvements, including design, material selection, packaging instructions, validation, testing, and technical documentation for sterile and non-sterile products. The position also coordinates instrument case development, supports packaging-related CAPAs, and provides documentation to Regulatory and Quality for submissions and audits. The engineer creates bills of materials and engineering change orders, collaborates with design teams and contract suppliers, and supports product design changes affecting packaging. The role requires advanced packaging design and validation expertise, technical documentation skills, project leadership, and the ability to coach technicians or junior packaging engineers.

Requirements

Bachelor’s degree in Engineering; preferably in Packaging Engineering.
At least 5 years of experience in packaging design and development or manufacturing.
Advanced capability in designing complex packaging and packaging instructions using CAD software such as AutoCAD or SolidWorks.
Proficiency leading design history file (DHF) projects for packaging and instrument cases.
Advanced knowledge of packaging validation processes required by quality and regulatory standards.
Advanced ability to research packaging materials and suppliers for manufacturing improvements or cost reductions.
Advanced ability to lead global packaging design or process-improvement projects.
Advanced ability to write and approve technical documentation internally and review and approve documentation from external packaging subcontractors.
Proficiency creating packaging procedures and providing training on procedures.
Advanced knowledge of design and manufacturing processes and the ability to incorporate improvements into designs.
Proficiency specifying and communicating packaging-related design or process improvements with manufacturing and contract packagers.
Proficiency supporting and participating in internal and external audits for regulatory compliance.
Complete understanding and application of relevant principles, concepts, practices, and standards, with full knowledge of industry practices.

Nice To Haves

Medical device packaging or manufacturing environment experience.

Responsibilities

Coordinate packaging development activities for new products and product improvement projects.
Create and maintain packaging engineering specifications using CAD, 3D modeling, or other software tools.
Create and maintain packaging designs for sterile and non-sterile products.
Select packaging materials based on product and sterilization requirements.
Create and maintain packaging instructions for final manufacturing packaging assembly.
Communicate packaging process validation activities to manufacturing or designated design team members.
Coordinate and execute packaging design validation activities after packaging process approval.
Oversee package testing to verify packaging and product viability, including sterile and non-sterile barrier protection.
Generate protocols, test reports, engineering adoptions, and test documentation in accordance with quality standards and approved documentation systems.
Ensure packaging development activities are completed before packaging design transfer.
Coordinate instrument case development for new products and product improvement projects.
Coordinate and create instrument case layouts with design teams and contract suppliers.
Create and maintain instrument case specifications.
Oversee design verification and validation activities for instrument cases.
Lead instrument case projects when the instrument case is a standalone new product introduction.
Support packaging engineering-related corrective and preventive actions (CAPAs).
Provide packaging documentation to Regulatory and Quality for 510(k) and ERC submissions and audits.
Create bills of materials and generate engineering change orders for new products, revisions, and maintenance.
Communicate with design teams and contract suppliers using project management tools and written and verbal communication.
Support product design changes that develop or improve existing products and affect existing packaging.
Coach, mentor, and supervise technicians and junior packaging engineers.