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Trivascular

MANUFACTURING & PROCESS DEVELOPMENT ENGINEER

 

Process Development and Manufacturing Engineers within TriVascular are passionate about driving excellence in the manufacturing of quality Medical Devices. They are dynamic in nature and relentless at discovering opportunities to improve the systems around them. They are intimate with cutting edge process technologies and are responsible for implementing process improvements while supporting the introduction of new products to the market.

 

OVERALL RESPONSIBILTIES

  • Supports manufacturing personnel and creates systems to aid in the production of multiple medical device families
  • Support new product development through engagement with the R&D group and guides Design For Manufacturing activities in the early phases of projects
  • Drives appropriate resolutions to manufacturing issues ensuring excellence in quality, cost and delivery
  • Participates and engages with multiple team members across all functional groups within TriVascular
  • Identifies operational waste and institutionalizes systems to improve TriVascular Core Operational Metrics – Throughput, Yield, Output, Productivity and Compliance
  • Accurately applies statistics and sound logical thinking to evaluate and understand manufacturing processes and makes robust recommendations for improvements
  • Coordinates the work of assigned technicians and takes responsibility for their results.
  • Maintains accurate manufacturing documentation
  • Aligns systems throughout the product Value Stream to create value for all customers
  • Focus on long term success by standardizing processes, eliminating variation and seeks perfection
  • Provide technical support for root cause analysis, identifies corrective actions and implement effective controls
  • Adheres to all TriVascular policies and procedures by being up to date with all TriVascular training requirements
  • Well versed in the implementation of Lean Principles and Six Sigma methodologies
  • Creates risk assessments and implements controls to mitigate risks as they are identified

     

    QUALIFICATIONS

  • B.S. Degree in Engineering with 0-5 years’ experience, or an M.S. with 0-3 years’ experience
  • Experience leading Process Validation efforts with new product process development in an FDA regulated manufacturing environment is highly desired. Experience in medical device field is extremely beneficial.
  • Understanding of Nitinol, PTFE, or Catheter based Delivery Systems is preferred.
  • The ability to successfully perform on cross-functional teams and understands the importance of team work.
  • Exposure to the use of continuous improvement tools such as Visual Management Systems, A3’s, DFMA and 6-Sigma.
  • Excellent analytical abilities and experienced with the use of Statistics to solve problems.
  • Understanding of SPC and the ability to use this information to eliminate variation.

 

PREFERRED KNOWLEDGE

  • Experienced user of Statistical Process Control (SPC)
  • Exposure to creating and interpreting research through the use Design of Experiments
  • Performed Process Validation by creating and executing protocols, reports, testing and reviews
  • Knowledge of 21 CFR Part 820 and regulatory requirements for Medical Devices
  • ISO 13485:2003, Medical Devices and ISO 14971:2007, Medical Devices
  • Familiarity with Quality Management Systems
  • Application of Risk Management as it pertains to Medical Devices
  • Implemented Design for Manufacturing/Assembly within new product development

To apply for this position, please visit www.trivascular.com/company/careers

and click the link at the bottom of the page.