Pivoting from defense optics to medical devices

I’m considering a move after 6 years designing imaging systems around SWIR/NIR sensors in defense, and I’m not sure how to translate that into medical-device roles. My latest build was a 940 nm fiber-coupled endoscopic module (f/2.2, 120° FOV) with tolerance/Monte Carlo automated in Python + OpticStudio; for hiring managers, does ISO 13485 and process rigor outweigh optical performance metrics, or should I emphasize photonic packaging (sterilizable fiber connectors, AR coatings) when positioning myself?

‌⁠‍⁠​‍​‍‌⁠‌​​‍​‍​⁠‍‍​‍​‍‌‍‌‌‌‍⁠‍‌‍‌⁠‌‍‍‌‌‍⁠‍‌‍‌‌‌‍‌‌‌⁠​‍‌‍‍‌‌‍⁠‍‌‍‌⁠​‍​‍​‍⁠​​‍​‍‌‍‍⁠​‍​‍​⁠‍‍​‍​‍‌‍⁠‍‌‍‌‌‌⁠‌⁠‌‌⁠⁠‌⁠‌​‌‍⁠⁠‌⁠​​‌‍‍‌‌‍​⁠​‍​‍​‍⁠​​‍​‍‌‍‍‌‌‍‌​​‍​‍​⁠‍‍​‍​‍‌‍⁠‍‌‍‌‌‌⁠‌⁠​‍​‍​‍⁠​​‍​‍‌‍‌​​‍​‍​⁠‍‍​‍​‍​⁠​‍​⁠​​​⁠​‍​⁠‌‌​⁠​‌​⁠​‌​⁠​​​⁠‌‍​‍​‍​‍⁠​​‍​‍‌‍‍​​‍​‍​⁠‍‍​‍​‍​⁠‌​‌​‍​‌‍⁠⁠‌‍‌‌‌‍‌‍​⁠​⁠‌‍‌‌‌⁠‌​​⁠​​‌​‌‍‌‍‌⁠‌‌​​‌⁠​‌‌‍‍⁠‌​‍‍‌⁠​‍​‍​‍‌⁠⁠‌

Translate your tolerance Monte Carlo into ‘design controls’; traceability beats flair: https://www.fda.gov/medical-devices/design-control-guidance-medical-device-manufacturers… Got a DHF snippet?

‌⁠‍⁠​‍​‍‌⁠‌​​‍​‍​⁠‍‍​‍​‍‌‍‌‌‌‍⁠‍‌‍‌⁠‌‍‍‌‌‍⁠‍‌‍‌‌‌‍‌‌‌⁠​‍‌‍‍‌‌‍⁠‍‌‍‌⁠​‍​‍​‍⁠​​‍​‍‌‍‍⁠​‍​‍​⁠‍‍​‍​‍‌⁠​‍‌‍‌‌‌⁠​​‌‍⁠​‌⁠‍‌​‍​‍​‍⁠​​‍​‍‌‍‍‌‌‍‌​​‍​‍​⁠‍‍​⁠​‌​⁠​⁠​⁠​‍​‍⁠​​‍​‍‌‍‌​​‍​‍​⁠‍‍​‍​‍​⁠​‍​⁠​​​⁠​‍​⁠‌‌​⁠​‌​⁠​‌​⁠​​​⁠‍​​‍​‍​‍⁠​​‍​‍‌‍‍​​‍​‍​⁠‍‍​‍​‍‌⁠​​​⁠‌⁠​⁠​⁠‌‍‌‍‌​​⁠‌‌‌‌‌​⁠⁠‌​‌​‌⁠‌⁠‌‌‍‌‌⁠‌​‌‌⁠⁠‌‌‌‌‌‍‍​‌​‌⁠​⁠​⁠​‍​‍‌⁠⁠‌