Medtronic is looking to solve healthcare challenges by developing and implementing innovative technologies and therapies. This role will contribute to advancing existing technology or introducing new ones, ensuring product quality, and adhering to project and process requirements.
Requirements
- Good grasp Risk Analysis concepts ISO 14971
- Good grasp Medical SW Development concept IEC 62304
- Basic computer hardware architecture (RAM, ROM, FPGA, firmware, etc.)
- Linux & Windows systems knowledge (bootloader, OS startup)
- Experience with performing FMEA (top-down, bottom up)
- Experience with risk management planning, risk management reporting
- Experience with SW testing a plus
Responsibilities
- Develops, modifies, applies, and maintains standards for software systems quality operating methods, processes, and procedures.
- Conducts evaluation of software systems activities including requirements, design, development, documentation, integration, test, verification and validation.
- Defines appropriate measures to ensure product quality.
- Develops overall operating criteria to ensure implementation of the software quality program according to project, process and contract requirements and objectives.
- Ensures that projects and process control documentation are compliant with requirements, objectives and/or contracts.
- Reviews software systems design, change specifications, and plans against contractual and/or process requirements.
- Provides or directs verification and validation of software system requirements, traceability, and testability.
Other
- Seasoned individual contributor.
- Works independently under limited supervision to determine and develop approach to solutions.
- Coaches and reviews the work of lower level specialists; may manage projects / processes.
- Communicates with senior internal and external customers and vendors.
- Exchange information of statuses, ideas and issues to achieve objective, and influence decision-making.
