Sr. Packaging Engineer

Overview

This position will be responsible for the design, development, and validation of primary and secondary packaging for the launch of new medical devices at Argon. The ability to work independently is essential in this role, which includes management of multiple projects simultaneously within tight project timelines.

What You Will Do

• Lead all packaging-related engineering activities for the development of new products within the New Product Development (NPD) department.
• Perform packaging engineering in a regulated environment and release compliant packaging designs by navigating c-GMP (current Good Manufacturing Practices), 21CFR820, FDA quality assurance requirements for design and manufacturing and packaging.
• Design, develop and qualify new primary and secondary packaging for sterile medical devices.
• Perform packaging related process validations (IQ / OQ / PQ) and test method validations (TMV).
• Establish cost estimates for packaging components and systems.
• Evaluate and recommend materials for packaging components during the design phase.
• Author package design validation plans, protocols, and reports. Work closely with external labs.
• Work closely with cross-functional teams to identify and resolve any packaging-related issues during the product development process.
• Develop and maintain packaging process documentation, including standard operating procedures, work instructions, and process control plans.
• Use structured project management process to execute projects on time.
• Conduct research and stay updated on industry trends and advancements in packaging technology and recommend improvements to current processes and techniques.
• Train and mentor junior engineers and technicians on packaging processes, and techniques, and provide guidance and support to other team members.
• Adhere to all safety and quality standards, regulations, and best practices in the manufacturing of medical products
• Communicate effectively with team members, management, and other stakeholders to provide updates on project progress and address any concerns or issues
• Act as a liaison between R&D, Tooling, Manufacturing, and Quality Engineering teams.

Skills For Success

Seniority level

Employment type

Industries

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