Packaging Engineer – Medical Device
These opportunities come along once in a career and when they do, they demand your attention. 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.
- 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
- Creates specifications for all packaging, establishes vendors as needed, defines procurement requirements
- Leads all validations relative to packaging, coaching, mentoring, writing and executing protocols including
- 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
- BS Packaging Engineering, other disciplines are acceptable with requisite packaging experience
- Minimum of 3 years’ experience in Medical Device or Combo product packaging
- In-depth knowledge of appropriate ISO and CFR regulations as well as other markets like CMDR, EU, etc.
- CAD experience, SolidWorks preferred
- 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
- Knowledge and experience in test methods