Packaging Engineer, Medical Devices

Franklin Lakes, New Jersey | Engineering

Packaging Engineer – Medical Device

These opportunities come along once in a career and when they do, you need to act.  Our client is a med device start-up involved in a novel technology that addresses an unmet clinical need and it is a group of people who have successfully introduced other new product concepts to the market with several start-ups. 

 

Your core packaging skills are requisite as we need you to walk in the door, ready to take on the responsibility of implementing new equipment, road-mapping the path to a successful packaging effort, interacting with vendors on sterilization needs, and training technical staff on the use of the equipment. 

 

You will work cross-functionally to ensure documentation is compliant to the needs of ISO 13485, 21 CFR 820, and FDA regulations; participating in Risk Analysis (14971), Data Collection/Analysis, Controls & Procedures.  Still interested?  Read on. 

RESPONSIBILITIES: (The first three are must haves)

  • Leads all packaging projects from ideation, through design & development, managing protocol writing, V&V, and testing
  • Facilitates and supports packaging systems’ evaluation ensuring compliance to ISO 13485, 21 CFR 820 and other regulations as required
    • Develops and validates packaging equipment processes, tooling, fixtures and related documentation to support manufacturing and Quality
    • Facilitate and/or support the selection and design of packaging materials
  • Creates specifications for all packaging and drawings, establishes vendors as needed, defines procurement requirements
  • Leads all validations relative to packaging, including
    • Sterilization (EtO and Gamma)
    • Labeling/printing
    • Aging validation
    • Integrity of the overall packaging validation
  • Provides coaching, mentoring, writing and execution of protocols
  • Supports the full transfer from development to manufacturing to ensure success including training of technical support personnel in equipment set-up and use, incorporating labeling and documentation needs
  • Train manufacturing on packaging assembly, sealing machinery use, and labeling equipment

REQUIREMENTS: 

  1. BS Packaging Engineering, other disciplines are acceptable with requisite packaging experience
  2. Minimum of 3 years’ experience in Medical Device or Combo product packaging
  3. Some experience across the breadth of the development process from R&D to Ops and including Quality
  4. In-depth knowledge of appropriate ISO and CFR regulations as well as other markets like CMDR, EU, etc.
  5. CAD experience, SolidWorks preferred
  6. Must be results oriented and responsive to the needs of the team and with a strong track record of meeting both cost and timeline deadlines
  7. Demonstrable experience in the drafting and execution of V&V protocols in a med device QMS
  8. Knowledge and experience in test methods 
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