Staff Software Engineer
Bayer U.S. LLC seeks a Staff Software Engineer to work in Indianola, PA. This is a hybrid office/work-from-home position that often requires working in office up to five (5) days per week for up to six consecutive months during a project lifecycle. Will be responsible for verifying of embedded as well as application software for complex system interactions in medical devices. Duties include: (i) Lead and manage verification planning, architect test strategy, and test execution, software-system integration, issue resolution, collaborate and drive programs with cross-functional teams across multiple geographies to support class-2 medical device that meets FDA design controls; (ii) verifying and validating embedded as well as application software for complex system interactions in medical devices to account for user interactions, performance, safety, and functionality; (iii)Fulfill activities to comply with the project deliverables outlined in the Design and Development Plans and Design Control Procedures, as applicable; (iv) Develop manual and automation verification protocols for the design and development of the system/subsystem, review requirements and deliverables, develop test scenarios, review, and approve protocols, manage, or perform the execution of the protocols, report issues, analyze results, write reports, generate requirement traceability matrices ; (v)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.
Must have a bachelor's degree (or foreign equivalent) in Computer Science, Electronics Engineering, Electrical Engineering, or a related field plus five (5) years of post-baccalaureate and progressively responsible experience in a related position.
Experience must include five (5) years applying Medical Device Standards in Class-2 Medical device development: ISO13485, IEC62304.ISO14971, FDA 21 CFR part 820.30.
Experience must include three (3) years with: (i) planning and prioritizing system integration, verification test plans and verification test execution of complex software systems for large programs; (ii) as a Test Architect in software verification of Class-2 medical devices, V&V Engineering and design controls, SDLC covering embedded and application software; (iii) communication protocols, such as CANOpen-Cia425, Transmission Control Protocol /Internet Protocol (TCP/IP), etc.; (iv) working in a matrix/hybrid organization structure with cross-functional leadership skills as well as troubleshooting and making quick decisions; and (v) Tools and Technologies in medical device industry: RQM, DNG, Jira, DICOM, HL7, MIRTH Connect.
Experience must include one (1) year in the medical device industry with Test Automation, Tosca.
Experience can be concurrent.
This is a hybrid office/work-from-home position that often requires working in office up to five (5) days per week for up to six consecutive months during a project lifecycle.
Apply at http://career.bayer.us, using reference code below or Careers_us@bayer.com with resume, salary requirements, and reference code below (Staff Software Engineer)
YOUR APPLICATION
Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and want to impact our mission Science for a better life, we encourage you to apply now. Be part of something bigger. Be you. Be Bayer.
To all recruitment agencies: Bayer does not accept unsolicited third party resumes.
Bayer is an Equal Opportunity Employer/Disabled/Veterans
Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.
In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.
Bayer is an E-Verify Employer. Location: United States : Pennsylvania : Indianola Division: Enabling Functions Reference Code: 801858 Contact UsEmail: hrop_usa@bayer.com