Senior Medical Device AI/ML Engineer (Medtech)

TL;DR

Senior Medical Device AI/ML Engineer (AI/ML): Developing machine learning pipelines and training models for FDA-regulated medical device software with an accent on image processing, regulatory compliance, and dataset validation. Focus on constructing robust software systems, drafting technical documentation for FDA submissions, and implementing high-quality testing methodologies for medical imaging.

Location: Remote (U.S. only, excluding Alaska and Hawaii)

Salary: $120,000–$150,000/year + 10%–12% annual bonus

Company

Remote-first company specializing in medical device software development and FDA regulatory consulting.

What you will do

• Design, train, and validate AI/ML models, including curating and tracking underlying datasets.
• Write clean, efficient code and implement robust testing methodologies for software systems.
• Collaborate with regulatory experts to write FDA-compliant technical documentation, including software requirements and risk assessments.
• Interview client engineers and analyze source code to document and validate the safety of medical device systems.
• Advise clients on configuration management, AI/ML data controls, and FDA-required development processes.
• Manage client relationships, project timelines, and technical communication to meet regulatory milestones.

Requirements

• Must be based in the United States (excluding Alaska and Hawaii).
• PhD, Masters, or Bachelors in Computer Science, Biomedical Engineering, or a related field.
• 3+ years of professional software engineering experience.
• 3+ years of experience with image processing and deep neural networks.
• Fluency in Python and PyTorch.
• English: Fluent communication (C1) required.

Nice to have

• Experience with medical imaging frameworks and formats like MONAI, DICOM, and NIfTI.
• Strong background in statistical methods for analyzing and validating results.
• Experience with regulated medical devices or client-facing consulting roles.
• Interest or professional experience in cybersecurity.

Culture & Benefits

• 401(k) with company contribution after six months.
• Company-provided health insurance.
• Annual company retreat and a remote-first culture since 2012.
• Dedicated professional development time (two hours every Wednesday).
• Internet reimbursement up to $1,200/year and equipment stipend of $750/year.

Hiring process

• Application review and cover letter evaluation.
• A series of interviews.
• Take-home activity focused on writing software documentation for a medical device.
• Two reference checks.