[Remote] Senior Software Design Assurance Quality Engineer

Note: The job is a remote job and is open to candidates in USA. LivaNova is a global medtech company focused on creating innovative solutions to improve patient outcomes. The Senior Software Design Assurance Quality Engineer will lead the development of software and firmware for medical devices, ensuring compliance with design control regulations and managing risk documentation.ResponsibilitiesServes 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 developmentProvide valuable technical feedback in code reviewsLead (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 mannerGenerates, maintains and updates risk management documentation throughout the life cycle of a productLeads the post-market cybersecurity process by monitoring potential threats and initiating further review and analysis with security expertsServes as a core team member for validation of software used in the manufacturing process by providing technical leadership and direction. Responsibilities include the completeness and accuracy of change impact assessments, validation compliance with regulation/procedures, change risk assessment sufficiency, and acceptance criteriaWorks with and manages suppliers as needed during development to support overall program needsEnsures compliance with software / firmware development and non-product software validation proceduresContributes to successful regulatory audits by coordinating back room / front room activities or serving as a subject matter expertSkillsExperience with developing software or firmware in the medical device industry including demonstrated proficiency in meeting the requirements of IEC 62304Develop 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 requirementsGain a full understanding and knowledge of how LivaNova devices are designed and manufactured, how they function, and how they deliver clinical benefitMaintain 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 devicesCollaborate with other areas within Quality to achieve quality objectivesPossesses 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 requirementsBS in Computer Engineering / Computer Science / Electrical Engineering (with education/experience in software development) preferredBenefitsHealth benefits – Medical, Dental, VisionPersonal and Vacation TimeRetirement & Savings Plan (401K)Employee Stock Purchase PlanTraining & Education AssistanceBonus Referral ProgramService AwardsEmployee Recognition ProgramFlexible Work SchedulesCompany OverviewLivaNova is a medical technology company that specializes in advanced cardiac surgery, neuromodulation, and circulatory support solutions. It was founded in 1987, and is headquartered in London, England, GBR, with a workforce of 1001-5000 employees. Its website is http://www.livanova.com.Company H1B SponsorshipLivaNova has a track record of offering H1B sponsorships, with 2 in 2026, 15 in 2025, 7 in 2024, 6 in 2023, 7 in 2022, 9 in 2021, 7 in 2020. Please note that this does not guarantee sponsorship for this specific role.