Software Design Assurance Quality Engineer

About the Role

Key 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 development.
• Provide valuable technical feedback in code reviews.
• Lead and oversee investigations of software/firmware related complaints, defects, or nonconformities, identifying root causes and corrective actions in a timely manner.
• Generate, maintain, and update risk management documentation throughout the product lifecycle.
• Lead the post-market cybersecurity process by monitoring threats and initiating review and analysis with security experts.
• Serve as a core team member for validation of software used in manufacturing, ensuring validation compliance and change impact assessments.
• Work with and manage suppliers 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 activities or serving as a subject matter expert.

Requirements

• Experience with developing software or firmware in the medical device industry, including proficiency in IEC 62304 requirements.
• 8+ years of experience.
• Full accountability for representing Quality Engineering on project teams.
• Ability to present procedural requirements and design deliverables clearly during audits and regulatory inspections.
• Strong knowledge of pertinent regulations such as ISO 13485 and 21 CFR Part 820.
• Develop and maintain positive relationships with internal teams such as R&D, Clinical, Regulatory Affairs, and Operations.
• Understanding of how LivaNova devices are designed, manufactured, and function.
• Maintain and improve technical knowledge in software/firmware development and testing.
• Strong leadership skills with the ability to influence peers and team members.
• Excellent written and verbal communication skills.
• Ability to prioritize and plan activities.
• Educational background in Computer Engineering, Computer Science, Electrical Engineering, or related fields; advanced degrees or certifications are valued.

Nice to Have

• Advanced degree or professional certifications in relevant fields.

Qualifications

• BS in Computer Engineering, Computer Science, Electrical Engineering (with education/experience in software development) preferred
• Advanced degree or professional certifications are valued

Benefits & Perks

• 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