Bayer is seeking to solve the world's toughest challenges in health and hunger, aiming for a future where 'Health for all Hunger for none' is a reality. This role contributes to making that vision a possibility by developing software for medical device programs/products.
Requirements
- Currently pursuing a bachelor’s or graduate degree in Biomedical Engineering, Computer Engineering, Software Engineering, Electrical Engineering, Electronics Engineering or related field;
- Prior internship experience in Software Development and Testing in a regulated industry verifying and integrating software for complex projects;
- Prior internship experience in all phases of Software Development Lifecycle process using Waterfall and Agile methodology;
- Prior internship experience in technical writing ability;
- Knowledge of medical device regulatory processes.
Responsibilities
- Collaborate with Software Engineers and stakeholders to capture and develop written computer-based requirements (system, software, etc.) for medical device software development programs/products, including: Application software; Embedded software; Platform software; Operating system software.
- Transform software lifecycle concepts and needs definitions into Design Input requirements;
- Perform analysis and development of software design input requirements, including: User interface and interactions; Performance and reliability; Safety and interoperability; Stakeholder needs.
- Participate in Design Review of software design input requirements;
- Assist with activities to comply with the project deliverables outlined in the Design and Development Plans and Design Control Procedures, as applicable;
- Ensure compliance with standard operating procedures for medical device development, including compliance with ISO 13485 and IEC 62304;
- Perform critical analysis of technical situations, identifies problems, and work with the cross-functional team in resolving the problems;
Other
- Ability to troubleshoot and make quick knowledge and experience-guided decisions;
- Excellent written and oral communication skills;
- Excellent people skills, ability to partner well, good team camaraderie;
- Clearand concise writing easily understood by multiple audiences (testers, auditors, peers, etc.);
- Ability to work in-office in a hybrid fashion - 4 days a week in office.
