At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.

Principal Quality Engineer, Medical Device Software (SiMD)

The Principal Quality Engineer: Medical Device Software (SiMD), as part of Bayer’s Radiology Software Assurance and Operations Team, will be responsible to perform software quality management activities of complex 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. This position can be residence-based within the US and offers opportunities for global travel (but this is not a requirement).

YOUR TASKS AND RESPONSBILITIES

The primary responsibilities of this role, Principal Quality Engineer: Medical Device Software (SiMD), are to:

• Perform 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;
• Ensure development initiatives of Bayer 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;
• Conduct 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;
• Review 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 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;
• Provide guidance to cross functional teams to ensure software quality objectives are met for medical device software development;
• Engage 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;

• This role will be a residence-based position in the US.
• Visa Sponsorship may be offered for this role.

WHO YOU ARE

Your success will be driven by your demonstration of our LIFE values. More specifically related to this position, Bayer seeks an incumbent who possesses the following:

Required Qualifications:

• Minimum of a Bachelor’s degree in Computer Engineering, Electronics, Electrical Engineering, or similar technical field;
• Significant and relevant work experience in software engineering or quality engineering in medical device development;
• Relevant work experience in software quality management or device quality management of Class 2 or Class 3 medical devices including Software in Medical Device (SiMD) or Software as Medical Device (SaMD);
• Demonstrated experience in interpreting industry standards for medical device development and updating processes and procedures:
  • Quality Management System – ISO 13485
  • SiMD – IEC 62304
  • FDA 21 CFR 820.30
• Demonstrated 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.);
• 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 skills;
• Excellent people skills, ability to partner well and foster strong team camaraderie;
• Proficient with Microsoft Office tools especially MS Word, MS Excel, MS PowerPoint, MS Project, and other management tools.

Preferred Qualifications:

• Minimum of 10 years of relevant work experience in software engineering or quality engineering in medical device development;
• Minimum of 5 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 4 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 4 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;
• 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, and post-launch support activities;
• 2 or more years of programming experience in any of the following languages C, C#, Java, React JS, and/or Angular;
• Working knowledge of tools including JIRA, AWS, GitHub, Rational Quality Manager, and DOORS Next Gen;
• Working knowledge on OS such as Windows and Linux.

Employees can expect to be paid a salary between $108000 to $162000. Additional compensation may include a bonus or commission (if relevant).

Other benefits include health care, vision, dental, retirement, PTO, sick leave, etc. If selected for this role, the offer may vary based on market data/ranges, an applicant’s skills and prior relevant experience, certain degrees and certifications, and other relevant factors.

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