I am a biomedical engineer with multiple master's degrees and 25+ years of experience in the field. I even studied FDA regulations at a law school. I have written thousands of engineering documents for FDA compliance many times at different medical device companies. But Medtronic sent my job to India.
Since I do have 25+ years of experience, when a company in a regulated industry sends its work to India, the quality of compliance engineering usually drops. I worked at one firm where the medical device company sent its requirements documentation to India to save money. After about a year, it wasn't working out at all. So, an American-based team in Miami with principal-level engineers had to rewrite it from scratch. I predict this is happening right now for Medtronic. But those VPs overrule it. I know there were mid-level directors who foresaw that as a big risk. Some of them left or just got laid off.
So, why does that happen - the drop in quality of engineering compliance? Usually, it's a variety of factors like time zone difference, culture gap, extreme distance, challenges for English as a 2nd language, and lack of experience. Given the "woke" culture, if an engineer brings up the issue of "English as a 2nd language" then someone usually pulls the race card rather than deal with it. I've seen that happen multiple times with offshore teams. Rather than admit their writing su-ks, they'll just yell racism in a variety of ways. BTW - I am a bilingual speaker of English and another language as a minority engineer. So, I know when someone struggles with English as a 2nd language. It's common with offshore teams. Are there exceptions? Sure. But it would be naive to assume the cluster doesn't exist.
But I'm having great fun doing research on AI for medical imaging. I work with a group affiliated with the Mayo Clinic over in Rochester. I gave up on the medical device industry and work in finance now. But I still do academic research outside of work with medical imaging and AI. It's very rewarding - no ugly corporate politics and no offshoring. I had a meeting with two principal scientists today to discuss fMRI and DTI data processing. The research of AI and medical imaging is fascinating. One can still enjoy such research without dealing with the corporate nightmares of the medical device industry.
BTW - be sure to lookout for that FDA Audit Inspector when that offshore team has to show its documentation for compliance engineering. I doubt they can make the cut. I've seen it fail multiple times.