Sr Manufacturing Enginer in Athens, TX at Volt

Date Posted: 9/14/2018

Job Snapshot

  • Employee Type:
    Direct Hire
  • Location:
    Athens, TX
  • Duration:
    N/A
  • Date Posted:
    9/14/2018
  • Job ID:
    137932
  • Pay Rate
    $90000.0 - $110000.0/Year
  • Contact Name
    Volt Branch
  • Phone
    972-518-0156

Job Description

Are you a seasoned Manufacturing Engineer with Medical Device experience or a desire to learn about Medical Device Manufacturing.

If so, this may be the position for you!

Qualifications

  • 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

RESPONSIBILITIES

  • 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