Senior Software Engineer - V&V - Indianola, PA- Hybrid

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.

Senior Software Engineer - V&V - Indianola, PA- Hybrid 

Senior Software Engineer - V&V – Indianola, PA- Hybrid

PURPOSE

System software verification and validation of radiology device products to meet FDA design controls. 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 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 manual and/or automated software verification protocols, including: 
  • 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 of the defects;
• Lead V&V activities for projects of moderate complexity;
• 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;
• Effectively collaborate within cross-functional teams across multiple geographies in identifying problems, provide guidance and consulting to the team on technical and process issues, critical analysis, opportunities, solutions and results in the medical device development;
• Engaging in continuous improvement initiatives to establish Center of Excellence (CoE) in Software Assurance function.

WHO YOU ARE

Bayer seeks an incumbent who possesses the following:

REQUIRED QUALIFICATIONS

• Must have bachelor’s degree in engineering (or foreign equivalent degree), in Computer, Electronics, or Biomedical;
• Significant experience with Verification and Validation activities and experience must include applying Medical Device Standards in Class-2 Medical device development and qualification: ISO13485, IEC62304.ISO14971, FDA 21 CFR part 820.30;
• Familiarity with Software Development Lifecycle processes, including Waterfall and Agile methodologies;
• Technical writing ability – clear and concise writing easily understood by multiple audiences (testers, auditors, peers, etc.);
• Have a strong sense of ownership and project outcome;
• This is a hybrid office/work-from-home position that often requires working in office up to five (5) days per week during a project lifecycle/release depending on the stage of the project.

PREFERRED QUALIFICATIONS

• 5+ Years of experience with Verification and Validation activities and experience must include five (5) years applying Medical Device Standards in Class-2 Medical device development and qualification: ISO13485, IEC62304.ISO14971, FDA 21 CFR part 820.30;
• 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;
• Working knowledge of tools such as Rational Quality Manager, DOORS Next Gen, Jira DICOM, HL7 Mirth Connect;
• 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;
• Working in a matrix/hybrid organization structure with cross-functional leadership skills as well as troubleshooting and making quick decisions;
• Tools and Technologies in medical device industry: RQM, DNG, Jira, DICOM, HL7, MIRTH Connect.

#LI

#LI-AMS