Medical Device Software Engineer at Innolitics

Innolitics builds AI/ML software for medical devices — the kind that detects ear infections, tracks metastatic cancer, and plans radiation therapy. 60+ FDA clearances. We're a remote-only firm (since 2012) that does engineering, regulatory, and cybersecurity under one roof. Our team includes MDs, PhDs, and software engineers. Clients range from Series A startups to large device companies. We're hiring for three roles:
1. Physician-Scientist (MD/PhD) — Biostatistics & AI Software Development: MD + PhD in biostatistics, bioinformatics, epidemiology, or a related quantitative field. You'll design biostatistical plans for AI validation studies (MRMC, standalone, prospective), build production-grade statistical software and data pipelines, write FDA-facing statistical sections, and analyze large clinical imaging datasets. Fluent in Python and/or R. This is not a pure research role — you'll ship code that gets FDA-cleared and deployed in clinics.

2. Senior Web/Mobile Medical Device Engineer: 5+ years software engineering experience. 3+ years each in web and mobile. Fluent in Type Script and Python. You'll build medical device software and produce FDA-facing technical documentation. Cross-functional role bridging engineering and regulatory teams.
3. Medical Device Software Engineer: 3+ years software engineering experience. Fluent in Python, C++, or Type Script. Heavier emphasis on software development initially; you'll grow into regulatory documentation work over time. All roles involve writing production code for medical devices, authoring documentation for FDA submissions, and working directly with clients. No prior medical device experience required — training provided. Why engineers stay here:
Agentic AI tools (Claude Code, etc.) are part of our workflow as an impact multiplier. ~1 hour of meetings/week for ICs. Flexible hours. 2 hours every Wednesday dedicated to learning ("10x Time"). Healthcare-only revenue. No debt. Never had a layoff. We pay $300 for take-home exercises. Stack:
Python, Type Script, C++, R, Django, React, Tensor Flow, PyTorch, scikit-learn, Qt, Terraform. Apply:  Handbook:  Medical Device Software Engineer @

Location:

** REMOTE (US)
** Job Posted:
** 2 weeks ago*
* #J-18808-Ljbffr