Systems/Controls Engineer II

Role: Support post-submission activities for a medical device program, focusing on in-sourcing third-party electronic designs and software documentation, cybersecurity compliance, and verification processes. Responsibilities: port third-party hardware schematics and software, generate technical and validation documentation, execute lab testing, and ensure compliance with FDA and industry standards. Requirements: Bachelor's in Electrical, Computer or Software Engineering; 3-7 years in microcontroller design and firmware programming; strong documentation and testing skills; ability to manage multiple assignments independently. Preferred: experience in medical device software verification and validation, familiarity with IEC 62304, ISO 14971, FDA guidance, and cybersecurity practices; scripting and source code reading skills; proficiency with tools like Altium, IAR, MS Office, Aras PLM. HighValue: medical devices, software validation, cybersecurity, FDA premarket guidance, lab testing, and documentation management. WorkSetup: not specified; likely office-based with potential for remote work based on organizational policies.