Software Quality Engineer

DEPARTMENT/TEAM DESCRIPTION

Radiology Software Assurance & Operations Team

Primary Function:

• Software Quality Management of Radiology device products to meet FDA design controls and other regulatory bodies
• Software Quality Management of GxP relevant computer systems

POSITION SUMMARY

This position will be responsible to perform software quality management activities of medical devices (Class-2) to deliver a high-quality product that meets or exceeds customer expectations and meets FDA design controls and other regulatory bodies.

POSITION DUTIES & RESPONSIBILITIES

Activities

• Software Quality Management of Software in Medical Device (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 Bayer Radiology medical devices complies and adheres 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 a.k.a SOUP) software use, Software as a Medical Device: Clinical Evaluation
• Conducts evaluation of 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
• Reviews all the deliverables of medical device software lifecycle and provide clear, concise, and timely feedback to stakeholders
• Responsible for ensuring computer system validation initiatives in Bayer Radiology organization complies and adheres 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 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

REQUIREMENTS/PREFERENCES

Skill & Competency Requirements:

• 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 Device (SiMD) or Software as Medical Device (SaMD)
• Minimum of 2 years or more of experience in interpreting industry standards for medical device development and updating processes and procedures
• o Quality Management System ISO 13485
• o SiMD - IEC 62304
• o SaMD - IEC 82304
• o FDA 21 CFR 820.30
• o 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
• o General Principles of Software Validation
• o 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

Preferences:

• 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

IMPORTANT NOTE for POTENTIAL US CANDIDATES: Bayer expects its colleagues to be fully vaccinated against COVID-19. Bayer defines fully vaccinated in alignment with CDC which is two weeks after completing the two-dose vaccine regimen or two weeks after completing the one-dose regimen. Additionally, Bayer colleagues are also required to comply with state, local and customer requirements.

BAY1JP00017248