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 DeviceArchitect 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
- 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
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.
Be innovative, be Bayer. Wij geven de toekomst van de dagelijkse gezondheid, patiëntenzorg en landbouw vorm. Samen kunnen we een positieve impact hebben op de gezondheidszorg en gezonde voeding voor iedereen. Geleid door ons doel ‘science for a better life’, geworteld in onze DSO aanpak en gestuurd vanuit de organisatiestrategie, kijken we uit naar onze ambitieuze visie. Help ons deze visie te realiseren: ‘Health for all, hunger for none’
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.
You can expect a response in the week of the 6th January
We do not accept any unsolicited applications and agencies.
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