Senior Software Design Assurance Quality Engineer

Location & Travel

Location:

Houston, TX preferred; open to remote for Senior level candidates. Travel:
Occasional Travel (up to 10%).

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).
• 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.
• Generate, maintain and update risk management documentation throughout the life cycle of a product.
• Lead the post-market cybersecurity process by monitoring potential threats and initiating further review and analysis with security experts.
• Serve as a core team member for validation of software used in the manufacturing process by providing technical leadership and direction.
• Ensure completeness and accuracy of change impact assessments, validation compliance with regulation/procedures, change risk assessment sufficiency, and acceptance criteria.
• Work with and manage suppliers as needed 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 back room/front room activities or serving as a subject matter expert.

• 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 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 Liva Nova 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 Liva Nova 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.

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.

• 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