ADI Principal Test Lead

ADI Principal Test Lead

As the ADI Principal Test Lead, you will be responsible for the software verification and validation of our class II and higher regulated AI/non-AI Software as a Medical Device (SaMD) products. You will guide and support junior and external Quality Assurance Engineers while driving process improvements in the software quality assurance and requirement areas.

As the ADI Principal Test Lead, you will collaborate closely with various departments both within and outside Bayer. You will regularly engage with the Technical Lead, Software Engineers, and Data Scientists to ensure project objectives are met and insights are integrated. Additionally, you'll work with the Radiology R&D and Digital Solution Business teams, as well as other software partners. Your role involves liaising with the quality department, Risk Management, Cybersecurity, Product Management, and Regulatory Affairs to ensure compliance with medical device standards, which is crucial for the success and quality of our projects.

YOUR TASKS AND RESPONSIBILITIES:

• Verification and Validation of AI/ML as well as non-AI/ML based Software as a Medical Device
• Architect test strategies, development and execution of manual and/or automated software verification protocols, including

- Requirement analysis and review

- Architect test strategy
- Design and development of test scenarios
- Authoring and review of test cases and protocols

- Performing execution of test cases
- Analyzing results, tracking discrepancies, and writing reports

• Deploy and maintain CI/CD (DevOps) pipelines, including

- Developing and maintaining Continuous Integration Deployment
- Testing infrastructure to accelerate product development cycle time
- Maintain test automation framework for medical device products
- Automating build creation and deployment, using Jenkins, AWS, and GitHub
- Scripting using Python, Perl, and other scripting languages

• Lead and manage verification and validation of complex AI/non-AI software projects with cross functional teams distributed across multiple geographies under new product development (NPD) and/or Life Cycle Engineering (LCE) initiatives of AI/ML based Software as a Medical Device development, provide guidance and consulting to the team on technical and process issues, review deliverables of the team
• Fulfilling activities to comply with the project deliverable outlined in the Design and Development Plans and Design Control Procedures, as applicable
• Ensure compliance with standard operating procedures for medica device development, including compliance with ISO 13485, IEC 62304, IEC

WHO YOU ARE:
•    Advanced academic degree (master's) in computing, engineering, or a related field
•    Several years of relevant work experience in software quality assurance, software engineering, requirement engineering, or risk engineering in healthcare software development
•    Experience as a Test Architect in Software Verification within regulated software development
•    Proficient in test automation and DevOps activities, with strong technical writing abilities
•    Technical writing ability: clear and concise writing easily understood by multiple audiences (testers, auditors, peers, etc.)
•    Prior experience of working in Quality Systems Regulations with knowledge of documentation systems (i.e., Verification/Validation
•    Protocols, SOPs, IBM RQM) required of a business in the regulated Industry
•    Prior experience designing and developing medical device software in a regulated environment while adhering to FDA Design Controls and software process guidelines for medical devices including ISO 13485, IEC 62304, IEC 82304 and FDA Design Controls CFR 820.30
•    Strong skills in in SDLC and STLC
•    Strong understanding of DICOM and medical imaging data
•    Distinct conceptual and result oriented thinking as well as customer orientation, high flexibility, and resilience
•    Fluent in English and German, both spoken and written; experience in an international environment is preferred

WHAT BAYER OFFERS YOU

As a modern employer, we take care of our employees and help them find a balance between career development opportunities and personal life planning. We offer our employees a wide range of career prospects, a modern working environment and competitive compensation. Bayer employees benefit from great employment conditions, such as:

• A gross monthly salary between €5500 and €6800 based on a 40-hour workweek, depending on your education and work experience
• An additional 8% holiday allowance, year-end premium, and a bonus (based on company results)
• 34 days of leave
• If you work from home, Bayer provides the required tools and a monthly internet allowance
• A solid retirement plan and bicycle lease plan
• An inspiring working environment with professional and committed colleagues
• A successful innovative organization with international career possibilities
• Challenges and possibilities to learn and to develop

This is a remote position open to candidates based in the Netherlands or Germany. Above conditions regarding Dutch local working conditions.

If the candidate is based in Germany, the conditions will be adjusted to local working conditions.

INTERESTED IN THIS VACANCY?
Are you looking for a new challenge? Apply online by sending us your resume and cover letter (in 1 document). Do you have a question or want to learn more about the position? You can always contact Nienke Klaar, nienke.klaar.ext@bayer.com .

What can you expect? The application process consists of a phone screening, a personality questionnaire, and an interview with the recruiter and hiring manager.

We do not accept any unsolicited applications and agencies.

#LI-BNL

Application Period:	18-11-2024	Reference Code:	834074
Division:	Pharmaceuticals	Location:	Remote (Dutch or German contract)
Functional Area:	Biological R&D	Position Grade:	VS 1.2
Employment Type:	Regular	Work Time:	Fulltime