Bachelorrsquos Degree in Engineering or Science with 4+ years of work experience in Quality andor Software Development OR Masterrsquos Degree in Engineering or Science with 2+ years of work experience in Quality andor Software Development. bull Experience working in a regulated industry (e.g., FDA-regulated). bull As a Quality Core Team member, collaborate with cross-functional project team members as well as members of the QA extended team. bull Demonstrate the ability and desire to work within a regulated medical device development environment, particularly based on the FDA Quality System Regulation and ISO 13485. bull Ensure internal Design Control policies and procedures comply with regulations and external standards, including software regulations, risk management, and change control. bull Identify and implement process improvements to increase efficiencies and product quality. bull Lead and drive collaborative design and development of medical devices. bull Participate in the development of requirements, software design, interface and test design. bull Collaborate develop SW FMEA to help drive good designs at early development stages. bull Collaborate and develop system hazard analysis. bull Ability to read software code and participate in detailed technical design and code reviews. bull Lead and drive CAPA projects. bull Collaborate effectively with the cross functional teams and other stakeholders. bull Demonstrate excellent coding, design and test practices. bull Understand the interdependencies of program work products and guide the teams in execution strategy and participating in development, review and approval of all program work products (e.g. plans, requirements, specifications, tests, test results, traceability, risk management documents, reports). bull Interact and form constructive working relationships with all levels of leadership within Quality, Marketing, RD, Systems Engineering and Operations. bull Provide training and coaching to cross-functional peers in maintaining compliance to internal and external Quality requirements and regulations bull Participate and support external regulatory audits and inspections. bull Provide solutions to a wide range of difficult challenges. Work independently to determine and develop solutions that are imaginative, thorough, practicable, and consistent with organizational objectives. bull Performs other related duties as assigned.