Medtronic is looking to solve complex health problems by developing and implementing new technologies and therapies, requiring individuals who can advance existing technology or introduce new ones.
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.
- Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.
- Communicates with senior internal and external customers and vendors.
