Argon Medical Devices
Sr. Manufacturing Engineer
Full-time
Argon Medical Devices
Argon Medical Devices
1445 Flat Creek Road
75751 Athens , TX
Job Description: 

This position will drive manufacturing engineering projects, including the design and development of processes, equipment, and documentation to successfully implement new products into manufacturing.  Enhance productivity and product quality of existing products and processes with a strong emphasis on Lean to ensure quality and manufacturability by enforcing engineering and manufacturing guidelines.  Effectively manage and communicate progress toward project goals to management. 

Responsibilities Include: 
  • Provide engineering support for the development and manufacture of Argon Medical Device products.
  • Evaluate proposed designs for manufacturability
  • Provide technical expertise for manufacturing support of polymer extrusion processes.
  • Recommend, develop and implement manufacturing related cost saving initiatives (Value Improvement Projects).
  • Develop and implement process validation protocols and reports.
  • Perform root cause analysis of product/process issues and implement short and long-term corrective actions to improve product quality and reliability.
  • Analyze and plan work force utilization, space requirements, and workflow and designs layout of equipment and workspace for maximum efficiency.
  • Confer with planning and design staff concerning product design and tooling to ensure efficient production methods.
  • 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.
  • Estimate production times, staffing requirements, and related costs to provide information for management decisions.
  • Confer with management, engineering, and other staff regarding production capabilities, production schedules, and other considerations to facilitate production processes.
  • Apply statistical methods to estimate future production requirements and potential.
  • Execute problem solving, efficiency studies, and the identification of process improvement opportunities.
  • Provide assistance in troubleshooting manufacturing and packaging areas.
  • 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.
  • Develop, implement, train and monitor effectiveness of engineering systems and procedures to ensure compliance to FDA, cGMP and all other applicable agency regulations
Education/Experience: 
  • Bachelor’s Degree or higher, in polymer engineering, material science, mechanical or industrial engineering
  • Minimum of five (5) years related experience in and FDA/GMP regulated industry
  • 2+ years of thermoplastic extrusion experience preferred.
  • Proficient in AutoCAD, SolidWorks, Minitab, Word, Excel and Project
  • Experience in product production planning and working knowledge of manufacturing methods, procedures and cost reduction/yield improvement techniques
  • Background in medical device assembly, automation, and vision system technology
  • 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 communication skills
  • Proven record of delivering multi-disciplinary projects on time and on budget
  • Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory and factor analysis
  • Define problems, collect data, establish facts, and draw valid conclusions
  • Interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables
  • Read, analyze and interpret general business periodicals, professional journals, technical procedures, or governmental regulations
  • Write reports, business correspondence and procedure manuals
  • Ability to drive change
  • 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
  • Function well within a team environment