Senior Design Quality Engineer - Peripheral Interventions

Representing the voice of quality as a Core Team member on product development team to ensure that design implementation meets the intent of product design while meeting quality standards and strategic business objectives. Develop and maintain understanding of the product/therapy space, including clinical use applications, to effectively integrate this knowledge with functional quality management system requirements. Application of Design Control and Risk Management processes throughout product development lifecycle, independently or as a member of a team. Provide quality and compliance input to colleagues for project decisions and deliverables. Creation, execution, and documentation of System Design Validation & Verification activities such as protocols, test cases, reports, investigation and resolution of issues identified during test. Collaborate with cross-functional design team to support creation and documentation of Risk Management documentation such as Hazard Analysis, Task Analysis, Design Failure Mode and Effects Analysis, and Software Design Failure Mode and Effects and Analysis Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. Provides quality input as a subject matter expert and or independent reviewer. Support internal and external regulatory audits as required. Advise management on potential improvements or enhancements to quality systems, processes, and products in the company. Bachelor's degree in engineering, physics, math, or other science discipline, or equivalent. Experience in Complex Systems Development or Integration Engineering Variable and Attribute Test method generation and validation experience Prior exposure to risk management tools & methodologies such as hazard analysis, FMEA on detailed work with emphasis on accuracy and completeness Ability to collaborate and work on a highly matrixed and global team Experience with Class III Medical Devices