LivaNova

Senior Software Design Assurance Quality Engineer

LivaNova • $130K — $150K *
Houston, TX 77084In-Person
Healthcare
Less than 5 years of experience
1 month ago
Job Overview by Ladders

Qualifications

  • BS in Computer Engineering, Computer Science, or Electrical Engineering with experience in software development
  • Experience in software or firmware development within the medical device industry, specifically IEC 62304 compliance
  • Ability to build strong relationships with internal teams such as R&D, Regulatory Affairs, and Operations
  • In-depth understanding of LivaNova devices and their manufacturing and functional processes
  • Knowledge of applicable regulations like ISO 13485, 21 CFR Part 820, and experience ensuring documentation compliance
  • Technical proficiency in software/firmware development and testing methodologies

Responsibilities

  • Participate in software/firmware development teams, providing technical leadership
  • Chair change control boards for quality improvements
  • Conduct technical reviews of code for compliance and quality
  • Investigate software-related complaints and defects, leading corrective action efforts
  • Maintain documentation for risk management throughout the product lifecycle
  • Monitor cybersecurity threats post-market and initiate required reviews
  • Validate software used in manufacturing processes, ensuring regulatory compliance

Benefits

  • Medical, Dental, and Vision health benefits
  • Generous personal and vacation time
  • 401K Retirement & Savings Plan
  • Employee Stock Purchase Plan
  • Training and Education Assistance
  • Bonus Referral Program
  • Service Awards to recognize longevity
  • Employee Recognition Program
  • Flexible work schedules available
Full Job Description


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


The Software Design Assurance Quality Engineer both 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.

Job Functions
  • 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.
  • 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. Responsibilities include the completeness and accuracy of change impact assessments, validation compliance with regulation/procedures, change risk assessment sufficiency, and acceptance criteria.
  • Works with and manages suppliers as needed during development to support overall program needs
  • 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.


Minimum 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 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 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 to provide value added feedback for new product development, investigations, and product/process changes to ensure the safety and effectiveness of LivaNova 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.


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.


Employee benefits include
  • 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


About LivaNova

LivaNova is a global medical technology company that develops and manufactures innovative therapeutic solutions for patients with chronic and acute conditions. The company operates in two business units: Cardiac Surgery and Neuromodulation. LivaNova's products include heart-lung machines, oxygenators, autotransfusion systems, and neuromodulation devices. The company was formed in 2015 through the merger of Sorin Group and Cyberonics. LivaNova is headquartered in London, UK, and has operations in more than 100 countries.
Learn more about LivaNova
Size
3,000 employees
Market Cap
$2.9 billion
Industry
Healthcare
Net Income
-$345 million
5 Year Trend
+1.4%
Revenue
$934.2 million
NASDAQ
LIVN
* Ladders Estimates

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