Senior Software Design Assurance Quality Engineer

Job Summary

The Software Design Assurance Quality Engineer plays a crucial role in the development of product and non-product software and firmware, serving as a core team member. They are responsible for risk management, compliance with design control regulations, and leading investigations into software and firmware issues.

About the Role

LivaNova is a global medtech company dedicated to creating innovative solutions that improve patient outcomes. This role offers the opportunity to join a dynamic team and contribute to the development of cutting-edge medical devices.

Responsibilities

• Serve as a core team member on software/firmware product development teams, providing technical leadership and direction.
• Manage the risk management file, ensure compliance with design control regulations, and lead investigations into software/firmware related complaints.
• Oversee the validation of software used in the manufacturing process, ensuring change impact assessments, validation compliance, and corrective actions.
• Work with suppliers to support overall program needs and ensure compliance with relevant procedures.
• Collaborate with other areas within Quality to achieve quality objectives and maintain technical knowledge in software/firmware development.
• Contribute to successful regulatory audits by coordinating back room/front room activities and serving as a subject matter expert.

Requirements

• 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 proficiency in meeting the requirements of IEC 62304.
• Strong business relationships with key internal customers such as R&D, Clinical, Regulatory Affairs, and Operations.
• A full understanding and knowledge of LivaNova devices, their design, manufacture, function, and clinical benefit.
• Possess in-depth knowledge of pertinent regulations (e.g., ISO 13485, 21 CFR Part 820, etc.) to ensure compliance with company-wide functions.

Qualifications

• Technical expertise in software/firmware development and test.
• Ability to generate, maintain, and update risk management documentation throughout the product lifecycle.
• Leadership skills in managing change control boards and overseeing investigations.
• Knowledge of post-market cybersecurity processes and the ability to initiate further review and analysis with security experts.
• Experience with supplier management and coordination during development.
• Compliance with software/firmware development and non-product software validation procedures.

Skills

• Strong problem-solving and analytical skills.
• Excellent communication and collaboration abilities.
• Proficiency in software development tools and methodologies.
• Knowledge of regulatory requirements and standards.

Benefits

• Health benefits – Medical, Dental, Vision
• Personal and vacation time
• Retailer & Savings Plan (401K)
• Employee Stock Purchase Plan
• Training & Education Assistance
• Bonus Referral Program
• Service Awards
• Employee Recognition Program
• Flexible Work Schedules

Pay

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.