Sr. Packaging EngineerArgon Medical Devices, Inc. • Athens, TX, US
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Sr. Packaging Engineer
Argon Medical Devices, Inc. • Athens, TX, US
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job_description.job_card.job_descriptionBachelor's degree in Packaging, Mechanical, Materials Engineering or related Engineering field. A minimum of 5 years of experience in packaging of medical devices, pharmaceutical and / or combination products is preferred. Detailed knowledge of ISO-11607-1 and -2, ISO 13485, medical device packaging ASTMs, cGMP and medical device validation methodology Packaging systems, medical device class II and III, design verification and validation experience for primary, secondary and tertiary; flexible and rigid packaging applications Experience with different medical device package designs (i.e. FFS pouch, top lid rigid trays, pre-made pouches, etc.) Proficiency using solid modeling tools (SolidWorks preferred) Proven experience on forming and sealing packaging processes Statistical analysis using Minitab software (i.e. DOE, process capability, analysis of variances) Understanding of sterilization technologies (i.e. radiation and gas) and their impact on medical device packaging Not Applicable Full-time Medical Equipment Manufacturing
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
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Packaging Engineer • Athens, TX, US