Software Quality Engineer (Expert)

Indianola , Pennsylvania, United States

Job Reference 1235556

Location Indianola , Pennsylvania, United States

Industry Process - Life Science

Function Engineering & Design

Job Type Contract

Date Added November 30, 2023

Our client is seeking a Software Quality Engineer to work alongside the Radiology Software Assurance and Operations Team for a 6-month remote contract. In charge of the Software Quality Management of Radiology device products to meet FDA design controls and other regulatory bodies, and GxP-relevant computer systems.

Required Qualifications:
  • Bachelor’s degree in Computer Engineering, Electronics, or Electrical Engineering
  • Minimum of 7 years of relevant work experience in software engineering or quality engineering in medical device development
  •  Minimum of 2 years of relevant work experience in software quality management of Class 2 or Class 3 medical devices including Software in Medical Devices (SiMD) or Software as Medical Devices (SaMD)
  • Minimum of 2 years or more of experience in interpreting industry standards for medical device development and updating processes and procedures
  • Quality Management System – ISO 13485
  • SiMD – IEC 62304
  • SaMD – IEC 82304
  • FDA 21 CFR 820.30
  • 2017/745 – European Union Medical Device Regulation (EU MDR)
  • Minimum of 2 years or more of experience in applying industry standards for medical device development as follows
  • General Principles of Software Validation
  • FDA CFR Part 11 Compliance
  • Must be able to handle multiple tasks/projects and manage priorities accordingly.
  • Technical writing ability – clear and concise writing easily understood by multiple audiences (auditors, peers, etc.)
  • Ability to work in-office and remote

Responsibilities:
  • The successful candidate will be self-motivated and capable of working in a fast-paced, timeline-driven environment
  • Software Quality Management of Software in Medical Devices (SiMD) of Class-2 and Class-1 medical devices, including Application software, Embedded software, Platform software, Operating system software
  • Software Quality Management of Software as a Medical Device (SaMD) of Class-2 and Class-1 medical devices, including Application software, AI/ML software, Platform software including IaaS and PaaS, Cloud-based software
  • Responsible for ensuring development initiatives of the company's Radiology medical devices comply and adhere to regulatory standards and guidance such as FDA Design Controls CFR 820.30, IEC 62304 – Software in a Medical Device, IEC 82304 – Software as a Medical Device, IEC 14971 – Risk Management, ISO 13485 – Quality Management Systems, 2017/745 – European Union Medical Device Regulation (EU MDR) and various FDA guidance Pre-market submission guidelines, General Principles of Software Validation, Off The Shelf (OTS aka SOUP) software use, Software as a Medical Device: Clinical Evaluation
  • Evaluates software engineering activities of medical device development including requirements, software risk analysis, design, development, documentation, integration, verification, validation, and release to deliver medical devices that are safe, secure, and effective
  • Review all the deliverables of the medical device software lifecycle and provide clear, concise, and timely feedback to stakeholders
  • Responsible for ensuring computer system validation initiatives in company's Radiology organization comply and adhere to standards and guidance such as General Principles of Software Validation, Computer Software Assurance for Production and Quality System Software, FDA CFR Part 11 Compliance
  • Provides guidance to cross-functional teams to ensure software quality objectives are met for medical device software development
  • Engaging in continuous improvement initiatives to establish a Center of Excellence (CoE) in Software Assurance function such as Software Problem Resolution meetings and documentation, CAPA actions, Process and template updates and Audit support  

Preferred Qualifications:
  • Familiarity with AI/ML based medical device software quality management
  • 2 or more years of relevant work experience in various phases of software development lifecycle including requirements, architecture, design, development, testing, release, deployment, post-launch support activities
  • 2 or more years of programming experience in any of the following languages C, C#, Java, React JS, Angular
  • Working knowledge of tools including JIRA, AWS, GitHub, Rational Quality Manager, DOORS Next Gen
  • Working knowledge on OS such as Windows, Linux flavors
  • Demonstrated ability working in a matrix/hybrid organization structure
  • Ability to troubleshoot and make quick knowledge and experience-guided decisions
  • Excellent written and oral communication
  • Excellent people skills, ability to partner well, good team camaraderie
  • Proficient with Microsoft Office tools especially MS Word, MS Excel, MS PowerPoint, MS Project, and other management tools
close

Don’t see a job for you? Register for our candidate portal

Sign in or register for Airswift Digital to stay updated with recommended jobs.

Visit our candidate portal