Sr Packaging Engineer I

Principal Duties and 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 SolidWorks.

· 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.

This is not an exhaustive list of duties or functions and may not necessarily comprise all of the "essential functions" for purposes of the ADA.

Expected Areas of Competence (i.e., knowledge, skills, and abilities)

· 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 SolidWorks.

· Proficient with Microsoft Office Suite and MS Project.

Education/Experience Requirements

· 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 $83,000.00- 100,000.00