Consultant, Packaging Engineer, Medical Devices Summary Our client,a leading global medical device company, has engaged GForce Life Sciences to provide a Packaging Engineer who is responsible for testing, evaluating, and analyzing existing sterile medical packaging for use in new sterilization cycles, storage conditions, and distribution environments. This role ensures that current package designs and specifications remain suitable for changes in use and recommends design modifications or improvements to meet new technical and regulatory requirements. The position also leads Design Verification testing for new packaging designs and configurations, interprets and documents test results, and authors comprehensive test reports to support packaging system validation.
Responsibilities
Research, design, develop, modify, and verify components, modules, and sub-systems for medical device packaging systems with minimal supervision
Conduct or design product prototyping and testing.
Analyze and correct product design issues with minimal guidance
Interpret standards and FDA requirements for device packaging and validations.
Interpret and apply sterilization requirements/standards to packaging design and validation.
Establish test protocols driven by national and international standards and regulatory requirements.
Facilitate the testing of new products to verify product reliability.
Operate various test equipment, interpret test data, and report results for each validation/verification. Occasionally delegate testing to technicians as appropriate.
Work cooperatively with process development, quality, manufacturing, regulatory and marketing to ensure project success.
Research & acquire production material and equipment related to packaging configurations.
Coordinate documentation of work instructions for new packaging configurations.
Create material/equipment specifications.
Work independently as well as on teams to perform root cause analysis and provide solutions to the root cause.
Requirements
Bachelor of Science in Engineering, Packaging Engineering, Mechanical Engineering or Biomedical Engineering OR associate’s degree and 3+ years of experience
2 years of experience in packaging engineering and design verification testing