Medtronic is looking for a Senior Software Quality Engineer to join their Cranial and Spinal Technologies operating unit to represent the Design Quality Engineering team and work with cross-functional partners in defining the strategy and deliverables for software new product development projects.
Requirements
- Working knowledge with medical device design controls
- Working knowledge in software development (IEC 62304)
- Working knowledge in risk management (ISO 14971)
- Experience in product risk assessment, requirements management and tracing, defect tracking, configuration management techniques, and how they are applied in the software development lifecycle
Responsibilities
- Provide Software (SW) risk management technical leadership to Design Quality Engineering peers
- Lead risk management activities and participate on cross-functional teams to develop and maintain Product Risk Management Files
- Provide Risk analysis, including system level risk management reviews, Failure Mode and Effects Analysis, product risk assessments and assessing specific product issues for impact to patient and/or user safety
- Define appropriate measures to ensure software quality
- Actively participate in new product development lifecycle by engaging with cross-functional partners in early development phases on design concepts, development strategies, risk management, and verification and validation test approaches
- Support Software New Product Development, Design Control, and Design Transfer processes, as well as responsibility for Quality deliverables during product development
- Identify and implement software process metrics for the software product development lifecycle
Other
- Bachelors degree required in Engineering, Science, or a technical field
- Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience
- This position will be based onsite in Lafayette, Colorado.
