The Senior Field Assurance Engineer will apply engineering and statistical principles to evaluate product field performance. Interpret customer feedback with associated analysis results, monitor failure trends and complaint patterns as they emerge based upon statistical analysis. Develop and execute necessary plans for failure analysis test activities to ensure that product performance and overall product goals are met. Provide guidance/support in areas of process engineering, 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.The Senior Field Assurance Engineer will work with an existing team to drive root cause analysis for product returns. This person would review the failure characteristics (visual, mechanical, or electrical) and partner with the relevant design, applications, or product engineer to provide guidance on analysis techniques to be used to isolate root cause. A background in device design is a critical aspect of this position. This individual will also be requested to interface with the end customers.
Typical job duties:
- 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.
- Be “proactive” in implementing root cause analysis across existing product portfolio and within new products in process.
- Perform returned product analysis and failure investigation activities for manufactured products.
- 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.
- Assist in the development and composition of Quality Procedures related to product complaint investigations.
- Demonstrate high-level engineering critical thought processes in investigation conclusions that incorporate reported complaint details and clinical considerations.
- Prepare narrative responses and requested data for regulatory reports and inquiries (FDA, OUS Competent Authorities).
- Function as a primary contact point between Field Assurance, R&D, and QA as it relates to customer feedback investigations.
- Supervise Field Assurance Lab activities and personnel, as needed.
- Provide direction for failure analysis engineers to ensure that product returns are evaluated appropriately to ensure accurate and clear results, as well as potential root causes for identified failures.
- Perform review and approvals of product investigations completed by supporting engineers.
- Contribute to CAPA investigations, including appropriate documentation and proof of activity completion.
- Represent Field Assurance at Quality product performance meetings. Support and initiate discussions when new failure mode trends are identified, providing field and statistical performance data as it becomes available.
- Develop and maintain a robust process for identifying and monitoring root cause failure modes, frequency, and severity.
- Participate in product risk management file updates, including inputs to design and process failure mode effects analysis (dFMEA, pFMEA) and post-market surveillance reports.
- Maintain, monitor and report trend analysis information on company products.
- Deliver constructive feedback and provide quality leadership in a cross-functional environment.
- Perform other duties as assigned.
- Job ID 5690BR
- Aliso Viejo, California, USA
Apply for this job
- Bachelor’s degree, preferably in an engineering or scientific discipline, or equivalent combination of education and experience.
- Four (4) or more years of product analysis experience and/or customer complaint investigations as a Field Assurance or Quality Engineer in a regulated environment.
- Proven excellent technical writing skills, strong analytical and critical thinking skills, and strong interpersonal communication and presentation skills.
- Proficiency with trending and data analysis using Excel, MS Office, and Minitab, or equivalent.
- Experience in risk management activities to include product hazard analysis, FMEA, SPC (Statistical Process Controls) and other risk management tools.
- Basic knowledge of statistical tools and techniques, and root cause analysis tools.
- Experience in conducting failure investigations and/or performing failure analysis leading to Root Cause and Corrective Action
- Ability to effectively work cross functionally with other departments including Quality, R&D, Operations, Regulatory and Marketing.
- Problem-solving and troubleshooting skills.
- Positive, energetic approach to teamwork, with the ability to learn quickly and multi-task.
- Ability to manage shifting priorities on a regular basis during the day.
- Ability to respond to the urgent needs of the team, with proven track record of meeting deadlines.
- Experience analyzing vascular interventional medical devices
- Experience with Lean or Six Sigma improvement systems.
- Knowledge of 21 CFR parts 803.