LivaNova

Cloud Platform Design Assurance Engineer

LivaNova

full-time

Posted on:

Origin:  • 🇺🇸 United States

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Salary

💰 $130,000 - $150,000 per year

Job Level

SeniorLead

Tech Stack

AzureCloudCyber SecuritySDLCTypeScript

About the role

  • Collaborate with cross-functional teams to understand requirements and deliver cloud-based applications and services on Microsoft Azure.
  • Lead cloud platform qualification efforts, ensuring performance, security, and software validation requirements are met.
  • Take ownership of creating and maintaining standard operating procedures (SOPs) for key business processes for managing enterprise software applications and user accounts
  • Collaborate with cross-functional teams, including developers, product managers, verification testers and regulatory affairs, to effectively identify and resolve quality issues.
  • Participate in design and code reviews, ensuring quality standards and best practices are consistently met.
  • Serves as a core team member on product development teams to provide 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 methodology.
  • Lead investigations of software defects identified during development, nonconformities reported by users, or changes driven by audit and CAPAs.
  • Support the post-market cybersecurity process by monitoring potential threats and initiating further review and analysis with security experts.
  • Ensure compliance with procedures for software upgrade and deployment of maintenance releases to the field.
  • Responsibilities include the evaluating the completeness and accuracy of change impact assessments and verification and validation testing.
  • Ensure compliance with software development and non-product software validation procedures.
  • Stay up-to-date with the latest Azure technologies and best practices
  • Continuously improve QA processes and methodologies, leveraging industry best practices and innovative approaches.

Requirements

  • 8+ years of experience in quality assurance, design assurance, and SDLC within the Medical devices, MedTech or Life sciences domain
  • Track record of design and management of cloud data storage systems, or network managed enterprise software
  • Proven experience designing, developing, and deploying applications on Microsoft Azure
  • Experience with data analytics and machine learning is valuable
  • Excellent problem-solving and communication skills
  • Sustained record of performance during tenure in previous position