Our client is a commercial-stage orthopedic medical device company that is looking for an experienced Packaging Engineer to join their team and support their new product development initiatives.

POSITION SUMMARY:

The Packaging Engineer will be responsible for management and execution of packaging design and manufacturing activities. The Packaging Engineer develops sterile and non-sterile packaging systems, manages technical aspects of packaging contract manufacturing, and develops packaging manufacturing systems.

PRIMARY DUTIES AND RESPONSIBILITIES:

• Coordinates and monitors packaging projects and programs from inception through implementation. Establishes appropriate project schedules and prepares project reports periodically to outline progress.

• Manages activities at contract manufacturers, including providing project timelines, resolving issues, troubleshooting, and providing overall technical support.

• Travels to contract packaging sites to onboard suppliers, support audits, and troubleshoot as required.

• Applies knowledge of packaging materials, manufacturing methodologies, sterilization compatibility, and the distribution environment hazards to sustain and develop sterile barrier packaging solutions that meet medical device design requirements to our product portfolio.

• Specifies and develops packaging equipment and tooling for sterile packaging manufacturing. Drafts and executes Installation, Operation, and Performance Qualifications.

• Design/re-design package components and develop sterile and non-sterile packaging systems for new and existing medical device products with limited supervision.

• Defines applicable testing protocols and coordinates appropriate package and sterilization testing as required. Responsible for writing, reviewing, and approving of protocols and reports (internal and external).

• Interface with R&D, manufacturing, marketing, quality, and regulatory personnel to ensure user needs are met as well as compliance with company Medical Concepts Quality System requirements and FDA regulations.

• Develops engineering drawings for sterile and nonsterile package designs as required utilizing company CAD system (SolidWorks), and reviews final engineering drawings prior to approval.

• Develops material specifications for package components, prepares manufacturing process specifications for appropriate packaging processes, and responsible for change control activities and coordinating with sterile kit packagers- technical review of all the documentation sent/reviewed for MAPs, FMEAs, etc.

• Creates all packaging/labeling specifications and other technical packaging documentation for products.

• Coordinates with Regulatory Affairs and Quality on the requirements for package inserts, procedures, testing for packages and/or packaging materials, & labeling.

• Create Bill of Materials, Coordinate Instrument Case development activities, and generate Engineering Change Orders

KNOWLEDGE, SKILLS, AND ABILITIES:

• Must have expert knowledge of Design Control and Risk Management, ISO, AAMI, and ASTM industry standards as well as FDA regulatory requirements.

• Must have expertise in medical device sterile and non-sterile packaging design and manufacturing.

• Proficiency in creating packaging procedures and providing training on procedures.

• Must have knowledge of packaging and sterilization requirements such as ISO 11137, ISO 11607, and AAMI ST79.

• Ability to interact with remote manufacturing resources to ensure product meets company standards for sterile and non-sterile packaging systems.

• Must be able to use MS Office computer software including Word, Excel, PowerPoint, and Project

• Must demonstrate CAD expertise (Solidworks preferred) for packaging design.

• Must be willing to travel 15% of the time for vendor visits, audits, process troubleshooting, etc.

MINIMUM REQUIREMENTS:

• Bachelor's degree in Packaging or Mechanical Engineering or a related discipline

• Two (2) years of packaging engineering experience; preferably within an FDA compliant Title 21 section 820 environment (or equivalent Quality System).