Primary Talent Partners has a new contract opening for a
Packaging Engineer II with our medical device client in Memphis, TN. This is a 24-month contract with a potential for extension.
Pay:$45.00 - $55.00/hr; W2 contract, no PTO, no Benefits. ACA-compliant supplemental package available for enrollment. Candidates must be legally authorized to work in the United States and must be able to sit on Primary Talent Partners W2 without sponsorship.
Description:
The role entails self-management of Packaging Development activities including design and quality deliverables involving: Strategy, Requirements flow down, Reviews, Roadmap Alignment, Design Inputs, Design Outputs, Design Characterization, Usability, Risk management, Manufacturing support, Design Validation, Labeling, Change Management, and Support Issues.
- Designs, develops, and creates test protocols/reports for a wide variety of containers used for the protection, display, and handling of products.
- Determines packaging specifications according to the nature of the product, cost limitations, legal requirements, and the type of protection required, considering need for resistance to such external variables as moisture, corrosive chemicals, temperature variations, light, heat, rough handling, and tampering.
- Designs package exteriors considering such factors as product identification, Operating Room Workflow, aesthetic quality, printing and production techniques.
- Responsibilities may include documentation management and/or coordination of Good Manufacturing Practices (GMPs), and may support prototype line development in manufacturing facilities/plants.
- Responsible for ensuring EU MDR Guidelines are met, and suggest where remediation steps may be needed.
- Update existing files to meet state of the art file expectations.
Top 3 technical skills that are required for the role:
- Medical Device Packaging Design (Sterile Packaging / Steam Sterilization Cases)
- Project Management skills, including timeline management and design history file ownership (Excellent documentation/reporting skills/file organization)
- CREO drawing software – Fully capable and comfortable with CREO
Education Required:
- Bachelor of Science in Packaging, or Mechanical Engineering, or Biomedical Engineering
- Requires a Bachelor's Degree and minimum of 3 years of relevant experience, or advanced degree with 2 years of experience.
Years' Experience Required:
- Internship (2 to 7 years of experience preferred)
Responsibilities may include the following and other duties may be assigned:
- Designs, develops, and tests a wide variety of containers used for the protection, display, and handling of products.
- Determines packaging specifications according to the nature of the product, cost limitations, legal requirements, and the type of protection required, considering need for resistance to such external variables as moisture, corrosive chemicals, temperature variations, light, heat, rough handling, and tampering.
- Designs package exteriors considering such factors as product identification, sales appeal, aesthetic quality, printing and production techniques.
- Responsibilities may include documentation management and/or coordination of Good Manufacturing Practices (GMPs), and may support prototype line development in manufacturing facilities/plants.
Must Have Skills: - Design and development of a packaging system for terminally sterilized medical devices as per requirements established by ISO 11607-1 (Part 1: Requirements for materials, sterile barrier systems and packaging systems) and corresponding packaging ASTM and ISTA (International Safe Transit Association) standards.
- Validation of processes for packaging medical devices that are terminally sterilized as per requirements established by ISO 11607 2 (Part 2: Validation requirements for forming, sealing and assembly processes). These processes include forming, sealing and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems.
- Strong working knowledge of FDA Medical Devices Part 820 Quality System (QS) Regulation & Medical Device Good Manufacturing Practices
- Experience with medical devices sterilization methods (i.e., ethylene oxide, radiation, etc.)
- Experience implementing appropriate risk mitigation actions with knowledge of packaging or process and process Risk Management as per FDA & ISO standards.
- Six Sigma/ Design for Six Sigma experience, and/or knowledge of Process Excellence tools.
- Working knowledge of SolidWorks or other packaging CAD programs (i.e., TOPS, SolidWorks, CREO, etc.). Experience with Minitab or other statistical software.
- Medical Device Packaging Design and Process Development
Nice to Have skills:- Experience developing Medical Device Case and Trays used with Steam Sterilization
Primary Talent Partners is an Equal Opportunity / Affirmative Action employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws.
If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at info@primarytalentpartners.com
#PTPJobs
#LI-PTP