Lead Compliance Engineers; Indianapolis, IN

Job Description: 

Participate in device risk management activities, including device hazards analysis, software hazards analysis & cybersecurity risk analysis. Oversee & direct software Risk & Hazard analysis activities, including the identification of risk & mitigations. Review & provide input to the outputs of the risk management activities, ensuring compliance to RND Quality Management System procedures & IEC 62304 & ISO 13485 .  Send resume to: The RND Group, Inc., 5975 Castle Creek Parkway North Drive, Suite 250, Indianapolis, IN 46250.

About RND

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.

No recruiting firms, please