Senior Software Design Assurance Quality Engineer

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.

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
• Generates, maintains and updates risk management documentation throughout the life cycle of a product
• Leads the post-market cybersecurity process by monitoring potential threats and initiating further review and analysis with security experts
• Serves 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 criteria
• Works with and manages suppliers as needed during development to support overall program needs
• Ensures compliance with software / firmware development and non-product software validation procedures
• Contributes to successful regulatory audits by coordinating back room / front room activities or serving as a subject matter expert

Requirements:

• 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
• BS in Computer Engineering / Computer Science / Electrical Engineering (with education/experience in software development) preferred