V&V Software Engineer I - Indianola, PA

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.

V&V Software Engineer I - Indianola, PA 

V&V Software Engineer I – Indianola, PA

PURPOSE

This position will be responsible to perform software verification and validation of medical devices to deliver a high-quality product that meets or exceeds customer expectations and meets FDA design controls.

YOUR KEY TASKS AND RESPONSIBILITIES

• Verification and Validation of software for complex system interactions in medical devices, including:
  • Application software;
  • Embedded software;
  • Platform software;
  • Operating system software;
• Development and execution of automated and manual software verification protocols encompass: 
  • Design and development of test scenarios;
  • Authoring and review of test cases and protocols;
  • Performing execution of test cases;
  • Writing reports;
• Responsible for verification of the software platform of the medical device, including:
  • User interface and interactions ;
  • Performance and reliability;
  • Safety and interoperability;
• Review and analysis of product and software requirements;
• Defect characterization and reporting. Assist in triaging;
• Compliance with standard operating procedures for medical device development, including compliance with ISO 13485 and IEC 62304;
• Critical analysis of technical situations; identifies problems, and work with the cross-functional team in resolving the problems;
• Collaborating within cross-functional teams across multiple geographies to convey problems, opportunities, solutions, and results in medical device R&D activities;.
• Engaging in continuous improvement initiatives to establish Center of Excellence (CoE) in Software Assurance function;

REQUIRED QUALIFICATIONS

• Bachelor’s degree in engineering;
• Familiarity with Software Development Lifecycle processes, including Waterfall and Agile methodology;
• Experience with automation framework and automated testing with QT-Squish, Python, Tosca, experience with code reviews  
• Experience designing and developing tests for medical device software in a regulated environment while adhering to FDA Design Controls and software process guidelines for medical devices including ISO 13485 and IEC 62304;
• Technical writing ability – clear and concise writing easily understood by multiple audiences (testers, auditors, peers, etc.);
• This position requires the candidate to work from office in Indianola, PA

PREFERRED QUALIFICATIONS

• Bachelor’s degree in engineering, preferably Computer, Electronics, or Biomedical;
• 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 and IEC 62304;
• Experience with automation framework and automated testing with QT-Squish, Python, Tosca, experience with code reviews;
• Working knowledge on OS such as Windows, Linux flavors;
• Working knowledge of tools such as Rational Quality Manager, Jenkins, JIRA, Git and DOORS Next Gen.;
• 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 Outlook, MS Word, MS Excel, MS PowerPoint, MS Project, and other management tools.