Requisition ID: 58914 Title: Sr. 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 a Sr. Engineer I - Packaging 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 five 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 will be located at our corporate campus in Naples, FL. 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:
B.S. in Engineering required; preferably in Packaging Engineering
Minimum of 5 years post graduate experience in Packaging Design and Development or Manufacturing required
Medical device packaging or manufacturing environment experience preferred
Skills:
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 as required by quality and regulatory standards.
Advanced capabilities of researching new packaging materials and suppliers for manufacturing process improvements and/or cost reductions.
Advanced capabilities in leading Global Packaging Projects for design and/or packaging process improvements.
Advanced ability of writing and approving technical documentation internally.
Advanced capability of reviewing and approving technical documentation from external packaging subcontractors.
Able to coach, mentor, and supervise technicians and/or junior packaging engineers.
Proficient at creating packaging procedures and providing training on procedures.
Advanced knowledge of design and manufacturing processes and ability to incorporate improvements into designs
Proficient at specifying and communicating design, process, or other packaging related improvements with manufacturing and contract packagers.
Proficient at supporting and participating in internal and external audits in support of regulatory compliance.
Knowledge:
Complete understanding and application of principles, concepts, practices, and standards. Full knowledge of industry practices.
Reasoning Ability:
Develops solutions to a variety of complex problems. May refer to established precedents and policies.
Discretion/ Latitude:
Work is performed under minimal direction. Participates in determining objectives of assignment. Plans, schedules, and arranges own activities in accomplishing objectives. Work is reviewed upon completion for adequacy in meeting objectives.
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.
