Packaging responsibilities include design, testing, verification and implementation of all levels of sterile and non-sterile product packaging. This includes all levels of packaging design up to pallet configurations and shipping.
Sustaining responsibilities include all analysis, testing, reporting and documentation changes to on market IV set product. This includes any needed changes of components, materials of construction, labeling, set design and or instructions for use.
Essential Duties & Responsibilities
Duty #1 Use Agile to look up details of IV Sets and associated drawings and process changes through the Agile Document Change Management system.
Duty #2 Understand written Testing Specs and write protocols and reports to make informed decisions and execute changes to IV sets or set components.
Duty #3 Project Management. Execute small to medium projects with the ability to use MS Project to plan and establish needed resources.
Duty #4 Packaging. Conduct and lead Medical Device Packaging projects in both Sterile and Non Sterile product configuration.
Duty #5 Use basic statistics to evaluate data and make informed decisions.
Duty #6 Present to leadership with succinct verbal and written communication skills.
Duty #7 Coordinate with manufacturing plants for project execution.
Work on special projects as they arise
Knowledge, Skills & Qualifications
Understanding of Medical Device or Pharma regulated manufacturing environment to include CGMPs and documentation practices.
Ability to read basic drawings and IV set drawing designs.
Understand Medical Device packaging.
Office skills to include Word, Excel, Power Point, MS Project, Agile
Education and Experience
Bachelor's degree from an accredited college or university is preferred
Packaging Engineering, BioMedical Engineering, Industrial Engineering, Mechanical Engineering.
Working in a FDA regulated environment.
Project Management experience. The ability to structure and progressively manage project tasks and timelines.
Must be at least 18 years of age
Must pass pre-employment drug screen and background check
2 years minimum years of experience required working in a FDA regulated environment.
2 years experienced in Medical Packaging.
Project management experience.
Travel Requirements (only select one of the below options)
Physical Requirements and Work Environment (Office position may need to be edited depending on the position)
This job operates in a professional office environment and routinely uses standard office equipment.
This job occasionally requires traveling to the manufacturing plants and be involved in Validation Testing of product.
Physical Requirements and Work Environment (Manufacturing position may need to be edited depending on the position)
Work is performed in an office environment.
When in the Manufacturing Plant, work is performed in a clean room environment
Must be able to occasionally move and lift objects of up to 25 lbs when performing product testing of finished goods in a corrugate case.
We are an Equal Employment Opportunity Employer, Female/Minority/Veterans/Disabled/Sexual Orientation/Gender Identity.