The Software Engineer, Design Assurance is responsible for Software Design Assurance activities guiding product development teams to assure designs meet requirements and adhere to design control regulation. This position will continuously evaluate and analyze the product development cycle and provide recommendations for the design and creation of new products as well as adjustments and enhancements of existing ones. Moreover, the successful candidate will have exceptional problem-solving skills and will be a key player in software requirements development, risk management, V&V testing, and architecture, design and code reviews, ensuring compliance to Quality System Regulations (i.e. CFR 820, ISO 13485, IEC 62304) and providing value added technical feedback.
What will you do?
Apply design control and regulatory knowledge to provide guidance to product development teams for the quality of design inputs and outputs during the various phases of product development.
Participate in reviews of the requirements, design, implementation, and tests to ensure that all software performs as intended.
Perform risk management and root cause analysis of software anomalies both pre- and post-market.
Monitor cybersecurity threats and escalate threats that could impact our devices.
B.S. in Computer Science, Software Engineering/Science or related field and at least 6 years of experience in the medical software development process, with exposure to software design, development, debug and test practices.
The ideal candidate will have had experience implementing controls and performing risk assessments for cybersecurity.