Position Overview

Apply engineering and statistical principles to evaluate field performance of MicroVention’s product portfolio. Interpret customer feedback with associated analysis results and monitor trends of failure and complaint patterns as they emerge based upon statistical analysis. Coordinate, perform, and document failure investigations on customer complaints leading to the identification of root cause and corrective/preventive actions. Ensure product analysis and investigations are performed and documented in accordance with regulations and company procedures.
  • Coordinate product investigations to ensure timely completion and compliance with company procedures and regulatory requirements (i.e. 21 CFR Part 820.198, Medical Device Directive ”MDD,” ISO 13485, and other applicable quality and regulatory requirements/standards)
  • Develop and maintain test procedures to standardize post-market performance testing for MicroVention’s product portfolio. Standardize complaint investigation verbiage to ensure consistent and accurate documentation within the Quality System
  • Oversee and provide Root Cause Analysis guidance to Engineers, Technicians, and associates supporting investigations. Train incoming investigation team members as needed
  • Represent Field Assurance (Post Market Surveillance) in Risk Management meetings to drive product risk analysis documentation updates (e.g., dFMEA/pFMEA/uFMEA) as needed
  • Act as a primary point of contact for Field Assurance to R&D, Quality, and Manufacturing as required based on product evaluation results; communicate critical product evaluation findings to management as needed
  • Initiate and support discussions via the product quality meetings or other appropriate forum when new failure modes and trends are identified
  • Coordinate product investigations performed by 3rd parties and ensure investigations are adequately performed and documented within the Quality System
  • Perform additional duties as assigned
    1. B.S. in Engineering or equivalent experience
    2. Minimum five (5) years of product analysis experience and/or customer complaint investigations as a Reliability or Quality Engineer in a regulated design environment
    3. Experience with21 CRF Part 820.198
    4. Experience in conducting failure investigations, reliability testing, and/or performing failure analysis leading to Root Cause and Corrective Action
    5. Proven excellent technical writing skills, strong analytical and critical thinking skills, and strong interpersonal communication and presentation skills are required
    6. Knowledge and experience of FDA QSRs
    7. Basic knowledge of statistical tools and techniques
    8. Demonstrated applied knowledge of Quality tools such as Failure Modes Effect Analysis (FMEA), GD&T, GDP (GDocP)
    9. Ability to read and interpret CAD drawings
    10. Ability to effectively work cross functionally with other departments including Quality, R&D, Operations, Regulatory and Marketing
    11. Problem solving and troubleshooting skills
    12. Excellent interpersonal and communication skills
    13. Ability to respond to the urgent needs of the team, with proven track record of meeting deadlines
    14. Computer proficiency with Mini-tab or similar analysis program, Visio, and MS Office
    Desired Qualifications
    1. Experience with medical device product development life cycle, including risk management and design/process verification and validation
    2. Experience in risk management activities to include product hazard analysis (PHA), FMEA, and risk control measures
    3. ISO 13485 Design Control Procedures, and ISO 14971 experience