Design Assurance Engineer

Client seeks an experienced Design Assurance Engineer to support design control and risk management activities within a cardiovascular medical device environment. The role will focus heavily on remediating existing quality documentation while also supporting ongoing product development and lifecycle activities. Responsibilities: Review and remediate design control and risk management documentation Support design inputs/outputs, design verification, and design validation activities Lead Test Method Validation (TMV) efforts and support test method development Lead and update FMEAs, hazard analyses, and other risk management documentation Ensure compliance with ISO 13485, ISO 14971, FDA requirements, and internal quality procedures Support remediation as well as PDP/NPD activities Participate in design reviews and other Design Assurance activities Potentially own or support CAPAs and NCRs Work autonomously while partnering cross-functionally with Engineering, Quality, Manufacturing, and Regulatory teams

5+ years of Medical Device Design Quality / Design Assurance experience Strong Design Controls and Risk Management experience Design control and/or risk management remediation experience ISO 13485 and ISO 14971 experience Test Method Validation and test method development experience FMEA experience PDP/NPD experience Ability to work independently in a highly cross-functional environment Experience with products such as snares, clips, stents, or similar devices preferred Desired: Experience with Nitinol Experience with Cardiovascular products