Improving Quality of Life Through Innovation. Every Patient, Every Day
Senior Software Design Assurance Quality Engineer
Location
United States
Posted
53 days ago
Salary
$130K - $150K / year
Seniority
Senior
Job Description
Senior Software Design Assurance Quality Engineer
LivaNova
Role Description The 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. - 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). - Chairs the change control board within projects for change requests and defects identified during the course of development. - Provides valuable technical feedback in code reviews. - Leads (technical expert) and oversees/approves 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. - 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. 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. - 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. - 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.). Requirements - Strong understanding of software/firmware development processes. - Ability to work with and manage suppliers as needed during development to support overall program needs. Benefits - 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. Pay Transparency 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.
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