The successful candidate will have experience generating test cases from requirements documents for medical instruments. The candidate will execute test cases and generate execution reports. The candidate must be willing to learn about the requirements for evidence gathering necessary for FDA 510K submissions.
The majority of RND’s clients develop medical devices regulated by the FDA. The successful candidate will be able to quickly learn about FDA 21 CFR Part 820 – Quality System Regulation and IEC 62304 Software Development Lifecycle.
Required Skills and Qualifications:
- Write test cases – this is 80% of the job
- Execute tests – this is the other 20%
- Create and use a trace matrix – this is key to success
- Defect tracking and management
- Understanding of formal documentation process
- Experience with quality systems – ISO 14971, ISO 9000, IEC 63xxx
- A 2 year AS Degree required
- Minimum of 2 years’ experience is required
- Excellent oral and written communication skills are required
RND is a highly specialized software engineering firm dedicated to the FDA regulated medical device market. We work with companies by partnering with their product development organizations in providing project management, requirements management, software engineering, and product testing services as needed to complement our clients’ existing engineering departments.
RND develops software to assist with our client’s Next Generation medical device platforms and instruments. These platforms and instruments provide “breakthrough” technologies that are used to diagnose cancer and other diseases, develop personalized medicines, provide gene sequencing, and perform research to assist with developing other healthcare solutions.
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