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)
- 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
- BS Packaging Engineering, other disciplines are acceptable with requisite packaging experience
- Minimum of 3 years’ experience in Medical Device or Combo product packaging
- Some experience across the breadth of the development process from R&D to Ops and including Quality
- 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
- Demonstrable experience in the drafting and execution of V&V protocols in a med device QMS
- Knowledge and experience in test methods