Design Quality Engineer II

Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues Develops and executes plans for design control and risk management of complex projects Update and maintain risk management files, such as the Hazard Analysis, Task Analysis, and Design FMEA. Working knowledge of Design Controls. Provide design quality and compliance input to project teams for project decisions and deliverables (i.e., Design Change Analysis, Design Inputs, Design Outputs, Test Methods, Design Reviews, Design V&V, Usability Testing, SW Validation, Process Validation and Labeling). Promotes and influences compliance to BSC's quality, business and health & safety systems and market/legal regulations Checks and provides support in the execution and investigation of CAPAs, NCEP, Failure Mode Investigations, etc. Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedure. Bachelor's degree in engineering or science discipline, or equivalent. 3+ years experience in design assurance, quality, or related medical device or regulated industry experience Knowledge of basic Quality System Requirements and Good Documentation Practices High energy problem solver capable of driving items to closure. Adaptable and effective collaborator in a team environment and in self-directed work Strong communication skills (verbal & written) Experience with Class III Medical Devices Experience with Capital Equipment Experience with design control, risk management, and medical device standards compliance Experience with corrective and preventive action