Sr Packaging Engineer

Job Responsibilities

• Supports the design and development of new packaging systems and/or improvements from conception to launch following Design Control procedures.
• Packaging designs include cases, trays, containers, as well as sterile packaging including sterile barrier systems and transport packaging.
• Oversees design work, validation, and testing of sterile and non-sterile packaging systems, ensuring integrity, safety, and compliance with regulations.
• Develops project plans and manages critical project timelines.
• Collects cross‑functional and user feedback to define user needs, specifications, and performance criteria related to packaging systems including protection, sterility, and usability.
• Manipulates CAD models and engineering drawings primarily within Solid Works.
• Authors and maintains design control documentation within a DHF.
• Supports test strategy development and validation requirements for sterile and non‑sterile products and contributes to test protocol/report creation.
• Defines and coordinates packaging verification and validation activities, including distribution testing, seal integrity, shelf‑life/aging studies, and any other relevant testing and/or evaluations.
• Reviews design and materials for manufacturability, inspectability, and cost‑effectiveness.
• Participates in root cause investigations and corrective actions related to packaging systems including sterile barrier failures and distribution related issues.
• Supports creation and maintenance of Bills of Materials (BOMs).
• Owns and authors packaging procedures, work instructions, and processes as the Packaging subject matter expert.
• May participate in label creation and definition of other items comprising the final finished packaged good.

• Full working knowledge of and moderate level of experience with packaging development, including both sterile and non‑sterile systems, and familiarity with design control processes.
• Working knowledge of sterile barrier systems (SBS), including material selection, sterilization compatibility, and package integrity methods.
• Demonstrated ability to methodically investigate technical issues, identify appropriate solutions, and apply current technologies to resolve problems.
• Ability to develop and maintain project schedules and track cross‑functional team progress to meet deadlines.
• Ability to address nonconforming product, and provide sound technical recommendations.
• Professional, concise, and tactful communications with internal teams and external stakeholders, including surgeons and suppliers.
• Effectively communicates with internal personnel, external customers, and vendors to accomplish project objectives.
• Effective written and verbal communication skills, including the ability to create and deliver technical presentations.
• Familiarity with and ability to support Quality Assurance and Regulatory requirements applicable to the medical device industry.
• Ability to manage multiple projects at one time throughout all stages of the development process.
• Proficient in CAD design and engineering drawings, preferably using Solid Works.
• Proficient with Microsoft Office Suite and MS Project.

• Minimum B.S. degree from an ABET accredited school (or global equivalent) in one of the following engineering disciplines:
  Mechanical Engineering, Mechanical Engineering Technology, Industrial Engineering or Packaging Engineering.
• 3-7 years of experience in the Medical device industry, particularly in orthopaedic devices with sterile packaging systems.

• Travel Requirements:
  Up to 10%
• Salary Range: $83,000.