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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.


Minimum Qualifications

  • 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.

  • We are looking for a candidate being proficient in two or more of the following languages: C, C++, Java, JavaScript, HTML, C#, .NET

  • The ideal candidate will have had experience implementing controls and performing risk assessments for cybersecurity.

KP Recruiting Group was started to create a world-wide network of multi-level, highly skilled talent; that are either experts or working to become one, in their respective fields. Our process involves focusing on the talent, skills, and experience of an individual as a key indicator of the present and future value that they will bring to any organization.

In establishing a network, we are able to forge genuine relationships with talent and gain valuable insight that allows us to understand what motivates them. This data allows us to give strategic advice to our partners as they go through the process of managing their human capital.

See our jobs and apply here: https://kprecruitinggroup.catsone.com/careers/7781-General

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