Position Overview

Apply engineering and statistical principles to evaluate product field performance. Interpret customer feedback with associated analysis results, initiate and monitor trends of failure and complaint patterns as they emerge based upon statistical analysis. Establish and maintain trending triggers and standards for product performance. Develop and execute necessary plans for integrated reliability and/or failure analysis test activities to ensure product reliability and overall product goals are met. Provide guidance/support in areas of process engineering, product quality assurance and quality engineering to drive continuous process and product improvements based on sound engineering principles and field product performance. Coordinate/perform documented failure investigations on customer complaints leading to the identification of root cause and corrective/preventive actions. Duties might include:
  1. Prioritize and coordinate timely completion of complaint investigations, respective Corrective Action and Preventive Action decisions, and Device History Record (DHR) reviews, ensuring sound engineering analysis and review.
  2. Supports and initiate discussions via the product quality meetings or other appropriate forum, when new failure mode trends are identified, providing field performance data as it becomes available.
  3. Develop and maintain a robust process for identifying and monitoring root cause failure modes, frequency, and severity. Provide statistical data on product performance, effectively describing clinical observations and the relationship with device performance.
  4. Represent Field Assurance in product Risk Analysis updates. Participate in product risk management file updates for commercial product, including inputs to design and process failure mode effects analysis (dFMEA, pFMEA), post market surveillance reports (PMSR).
  5. Maintain, monitor and report trend analysis information on company products.
  6. Provide direction for failure analysis team to ensure that field returns are evaluated appropriately to deliver clear results and potential root causes for identified failures.
  7. Function as a primary contact point between Field Assurance, R&D, and QA as it relates to customer feedback investigations. Prepare response for regulatory inquiries (FDA, OUS regulators) as assigned.
  8. Conduct all engineering activities related to Field Assurance in compliance with FDA's Quality System Regulation, Medical Device Directive (MDD), ISO 13485, Canadian CMDR, and other applicable quality and regulatory requirements and standards.
  9. Support returned product analysis and failure investigation activities for manufactured products.
  10. Demonstrate high level engineering thought processes that are based on both driving business objectives and product quality improvements.
  11. Supervise Field Assurance Lab.
  12. Deliver constructive feedback and provide quality leadership in a cross-functional environment.
    1. BA/BS degree or equivalent experience
    2. Four (4+) years of product analysis experience and/or customer complaint investigations as a Reliability or Quality Engineer in a regulated design environment.
    3. Experience with medical device product development life cycle, including risk management and design/ process verification & validation
    4. Knowledge of reliability modeling, FMEA, theoretical concepts and applicable standards to ensure systems perform their intended function within acceptable limits.
    5. Proven excellent technical writing skills, strong analytical and critical thinking skills, and strong interpersonal communication and presentation skills are required.
    6. Experience with basic reliability analysis, industrial statistics Business Objects and/or Excel.
    7. Experience in risk management activities to include product hazard analysis (PHA), FMEA, and risk control measures.
    8. Knowledge and experience of FDA QSRs, ISO 13485 Design Control Procedures and ISO 14971
    9. Basic knowledge of statistical tools and techniques, and root cause analysis tools
    10. Experience in conducting failure investigations, reliability testing, and/or performing failure analysis leading to Root Cause and Corrective Action
    11. Demonstrated applied knowledge of Quality tools such as Failure Modes Effect Analysis (FMEA), GD&T, and Mistake Proofing/Poka Yoke (Preferred).
    12. Ability to read and interpret CAD drawings (Preferred)
    13. Ability to advocate product excellence and quality
    14. Ability to effectively work cross functionally with other departments including Quality, R&D, Operations, Regulatory and Marketing.
    15. Problem-solving and troubleshooting skills.
    16. Excellent interpersonal and communication skills.
    17. Positive, energetic approach to teamwork, ability to learn quickly and multi-task
    18. Ability to respond to the urgent needs of the team, with proven track record of meeting deadlines.
    19. Computer proficiency with Mini-tab or similar analysis program, Visio, MS Office.