Engineer, Sr. I - Packaging

Essential Duties and Responsibilities

• Coordinate Packaging Development activities for new MPIs 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 packaging process validation activities with manufacturing or designated design team member.
• Coordinate and execute packaging design validation activities post packaging process approval.
• Oversee required package testing to assure viability of packaging/product construct for sterile and non-sterile barrier protection.
• Generate protocols, test reports, and engineering adoptions and maintain 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 MPIs 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 CAPAs.
• 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 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.

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.

Education/Experience

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