The Packaging Engineer is responsible for assisting with all aspects of packaging and labeling design and development for medical devices in conformance with corporate procedures and US /EU Quality System Regulations. These duties include developing packaging designs and prototypes, manufacturing specifications, verification and validation activities. The Packaging Engineer will also assist in ensuring compliance of device labeling including packaging graphics and Instructions for Use.
Essential Duties and Responsibilities:
Assist in meeting requirements of European Medical Device Regulations (EU MDR) and US Food and Drug Administration (FDA).
Develop packaging concepts based on design inputs.
Develop packaging and labeling specifications, support prototype development, create and execute design verification and validation activities.
Develop packaging drawings, routers and bill of materials.
Develop market specific labeling, stickers and Instructions for Use.
Participate in the development and execution of installation, operational and performance qualifications (IQ, OQ and PQ) of packaging and labeling software and equipment.
Develop process for optimizing in house and outsourced product packaging and labeling.
Assist in developing procedures and work instructions associated with production, product labeling and stickering.
Investigate and report on industry and non-industry packaging technologies.
Assist in risk analysis documentation such as Failure Mode and Effect Analysis for product packaging and labeling.
Interact with production team and packaging automation engineers.
Interface and collaborate with various departments (Manufacturing, Quality, Regulatory, Marketing, Operations) and outside vendors to accomplish assigned tasks.
Perform other duties as directed.
Minimum of 1 year working as a Medical Device Engineer (Packaging and/or Manufacturing preferred).
Proficient in MS Office Suite required.
Proficient in device labeling software (e.g. Bartender) preferred.
Proficient in CAD design software (e.g. SolidWorks) preferred.
Ability to interact with colleagues and customers in a professional manner.
Experience/familiarity with U.S. FDA, EU MDR and ISO requirements for the design controls of medical devices preferred.