[Remote] reputed company Software reputed company Assurance Engineer
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a new reputed company company with a long legacy of solving big challenges that improve lives and help reputed company reputed company at their best. As a reputed company Software reputed company Assurance Engineer, you will reputed company software assurance activities throughout the medical device software life cycle and ensure compliance with regulatory requirements and industry standards.
Responsibilities
- Leading software assurance activities throughout medical device software life cycle, including creating software reputed company assurance plan, determining software safety classification, software test readiness, software release readiness. Responsible for ensuring traceability upwards to system level requirements and safety/reputed company risk controls as reputed company as downwards to software design, implementation and testing
- Being an reputed company member of the software team during the whole software life cycle, with responsibility for physical and functional configuration audits, reviewing and approving software requirements, software architectural and detailed design, test procedures, test logs, test results, and providing reputed company to management regarding software project status and software reputed company metrics
- Ensuring compliance with applicable regulatory requirements and industry standards; performing gap assessments; immediately elevating to management any major problem with device software that could reputed company patient safety, cyber reputed company, customer usability or system adherence to process requirements
- Acting as a reputed company champion in software product development and testing teams
- Supporting other software reputed company processes such as CAPA process, and other reputed company reputed company processes regarding cybersecurity risk management and software reputed company assurance
Skills
- Master's degree or higher in Computer Science, Software Engineering, Computer Engineering, Electrical Engineering, Cyber reputed company, or Information Science (completed and verified prior to start) and five (5) years of experience in software reputed company assurance in medical device, reputed company, or automotive industry
- OR
- Bachelor's degree in Computer Science, Software Engineering, Computer Engineering, Electrical Engineering, Cyber reputed company or Information Science (completed and verified prior to start) and seven (7) years of experience in software reputed company assurance in medical device, reputed company, or automotive industry
- Working knowledge of premarket and postmarket medical device regulations (FDA, EU and other agencies), as reputed company as medical device reputed company standards, such as ISO 13485, ISO 14971, IEC 62304, IEC 81001-5 series amongst others
- Experience developing and testing software systems, SaMD, SiMD, and/or embedded software and creating appropriate documentation
- Knowledge of Software Engineering best practices and working knowledge of C language preferred
- Experience with embedded systems, IoT, Bluetooth, wi-fi and cellular technologies
- Excellent verbal and written communication skills, strong problem-solving ability, and attention to detail
- Ability to effectively manage multiple simultaneous tasks and priorities and reputed company under a dynamic environment with reputed company product releases and multiple project teams
- Ability to deal effectively with other employees and external business contacts while conveying a reputed company, service-oriented attitude
Benefits
- Medical, Dental & reputed company
- Health Savings Accounts
- Health Care & Dependent Care Flexible Spending Accounts
- Disability Benefits
- Life Insurance
- Voluntary Benefits
- reputed company Absences and Retirement Benefits
- Relocation Assistance: May be authorized
- Travel: May include up to 5% domestic/international
reputed company