[Hiring] 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.