Senior Software Design Assurance Quality Engineer

Location & Travel Location: Houston, TX preferred; open to remote for Senior level candidates. Travel: Occasional Travel (up to 10%). Software Design Assurance Quality Engineer actively participates in the development of product and non-product (e.g., automated manufacturing test systems) software and firmware by serving as a core team member. Responsibilities Serves as a core team member on software/firmware product development teams by providing technical leadership and direction. Responsible for the risk management file, compliance with design control regulations, development of design requirements, architecture specifications, and design verification/validation (including unit and integration testing). Chair the change control board within projects for change requests and defects identified during the course of development. Provide valuable technical feedback in code reviews. Lead (technical expert) and oversee/approve investigations of software/firmware related complaints, defects identified during development, or from manufacturing nonconformities, audit responses and CAPAs to identify root cause and corrective actions in a timely manner. Generate, maintain and update risk management documentation throughout the life cycle of a product. Lead the post-market cybersecurity process by monitoring potential threats and initiating further review and analysis with security experts. Serve as a core team member for validation of software used in the manufacturing process by providing technical leadership and direction. Ensure completeness and accuracy of change impact assessments, validation compliance with regulation/procedures, change risk assessment sufficiency, and acceptance criteria. Work with and manage suppliers as needed during development to support overall program needs. Ensure compliance with software/firmware development and non-product software validation procedures. Contribute to successful regulatory audits by coordinating back room/front room activities or serving as a subject matter expert. Minimum Qualifications BS in Computer Engineering / Computer Science / Electrical Engineering (with education/experience in software development) preferred. Experience with developing software or firmware in the medical device industry including demonstrated proficiency in meeting the requirements of IEC 62304. Develop and maintain strong, positive business relationships with key internal customers such as R&D, Clinical, Regulatory Affairs, and Operations to fulfill design development activities, support audits/inspections, and develop and implement plans that will ensure company compliance with regulatory requirements. Gain a full understanding and knowledge of how LivaNova devices are designed and manufactured, how they function, and how they deliver clinical benefit. Maintain and improve technical knowledge in software/firmware development and test to provide value added feedback for new product development, investigations, and product/process changes to ensure the safety and effectiveness of LivaNova devices. Collaborate with other areas within Quality to achieve quality objectives. Possesses in depth knowledge of pertinent regulations (e.g. ISO 13485, 21 CFR Part 820, etc.) to assure the documentation of all company-wide functions meet these requirements and, when necessary, identify compliant, effective and efficient approaches to fulfilling such requirements. Compensation & Benefits A reasonable estimate of the annual base salary for this position is $130,000 - $150,000 plus discretionary annual bonus. Pay ranges may vary by location and are awarded based on experience. Health benefits – Medical, Dental, Vision Personal and Vacation Time Retirement & Savings Plan (401K) Employee Stock Purchase Plan Training & Education Assistance Bonus Referral Program Service Awards Employee Recognition Program Flexible Work Schedules #J-18808-Ljbffr LivaNova PLC