Argon Medical Devices
Packaging Engineer
Full-time
Argon Medical Devices
Argon Medical Devices
1445 Flat Creek Rd.
75751 Athens , TX
Job Description: 

The Packaging Engineer will provide support to the packaging engineering team and will be responsible for packaging validations and execution of packaging projects.

Responsibilities Include: 
  • Support the design of innovative packaging concepts for complex projects, including new product launches and existing products throughout all stages of product development from concept to launch.
  • Execute Packaging Validation which includes: IQ, OQ, PQ, protocol writing, execution and documenting final validation result, transportation simulation, accelerated aging, distribution scenarios, external global regulatory requirements, sterilization validation strategies for new products, supporting manufacturing changes.
  • Must possess a solid understanding of FDA Validation guidelines and industry best practice for this field
  • Recommend, develop and implement manufacturing related cost saving initiatives (Value Improvement Projects).
  • Facilitate transitional activities on packaging materials to reduce overall cost and increase throughput. This will include working with Purchasing and raw material suppliers to determine optimal design and material selection. 
  • Assist as a technical expert in the resolution of problem investigations concerning packaging components.
  • Prepare financial justification and evaluation of new packaging machinery proposals.
  • Train other packaging personnel on processes, materials etc.
  • Confer with vendors to determine product specifications and arrange for purchase of equipment, materials or parts and evaluate products according to specifications and quality standards.
  • Work in conjunction with Maintenance Department to identify, recommend and implement the upgrade and automation of current equipment and the purchase of new equipment within regulatory requirements.
  • The ability to work independently is essential in this role, which includes management of multiple projects simultaneously within project timelines.

LEADERSHIP RESPONSIBILITIES

  • Lead functional and cross-functional teams to achieve project goals.
  • Mentor junior manufacturing engineers in project management activities
Education/Experience: 
  • Bachelor’s degree in Engineering (packaging preferred), plus directly related experience (required).
  • Master’s degree with emphasis in mechanical, electrical, or industrial engineering (preferred).
  • Three (3) - Five (5) years packaging experience in a FDA/GMP regulated industry (pharmaceutical, medical devices or food).
  • Proficient in AutoCAD, SolidWorks, Minitab, Word, Excel and Project
  • Experience in the application of statistical techniques such as statistical process control, design of experiments, and problem-solving techniques is required. ·
  • Experience with design, review, execution, and approval of Installation, Operation and Process Qualification protocols and reports (IQ/OQ/PQ)
  • Excellent verbal and written communication skills
  • Proven record of delivering multi-disciplinary projects on time and on budget.
  • Ability to apply statistical methods to process analysis.
  • Define problems, collect data, establish facts, and draw valid conclusions
  •  Write reports, business correspondence and procedure manuals
  • Ability to lead cross-functional/department teams
  • Ability to prioritize for maximum results (multi-task management)
  • Effective multi-channel communicator
  • Function successfully in a high paced results-oriented environment
Work Environment: