Medical Device Software Engineer

Innolitics is a remote-only professional services firm. We help medical device companies—from startups to large corporations—develop software and AI for medical devices, validate safety and security, and navigate FDA regulations.

At Innolitics, we are at the forefront of a rapidly evolving industry that increasingly relies on software and AI. As part of our team, you’ll work on projects that improve patient care and safety. From developing AI-driven diagnostics to ensuring cybersecurity, you’ll push the boundaries of what's possible.

In this dynamic field, both regulations and technology are constantly changing. Success requires continuous learning and growth. We foster a collaborative and flexible environment that encourages this. For example, we dedicate two hours each week to "10x Time," where we explore technical and regulatory topics.

As a Medical Device Software Engineer at Innolitics, you will play a cross-functional role in both regulatory and software development projects. You’ll work on two types of projects:

• Design Assurance / Software Validation projects. Once you’ve built up some experience with the FDA’s medical device regulations, you’ll help our clients validate their software and create all of the software and cybersecurity documentation necessary for regulatory submissions.

The two types of projects overlap, as we need to validate the software we’re developing.

Currently, we have much more demand for software engineering projects; therefore, you can expect that will be your main focus for at least the first year or more of your time with Innolitics.

• Software Development:
  You’ll participate in the design and development of new medical device software. You'll write clean, efficient code and ensure it meets both functional requirements and regulatory standards. Your work will involve constructing software systems, drafting software unit and system tests, and implementing robust testing methodologies.
• Cybersecurity:
  With support from cybersecurity experts on our team, you’ll guide clients through cybersecurity threat modeling and security risk analysis, ensuring that their systems are secure and comply with FDA requirements. You'll suggest ways to improve compliance with cybersecurity controls throughout the software development lifecycle.
• Regulatory Compliance:
  Collaborate with regulatory professionals to write technical documents, such as software requirements specifications, software risk assessments, and software design specifications, in language that the FDA understands. You'll ensure that all software documentation complies with FDA guidance.
• System Understanding:
  Engage in detailed information gathering by interviewing client engineers, reviewing technical documents, and examining source code. You'll develop a comprehensive understanding of our client’s medical device systems and help validate that they’re safe and document their functioning.
• Configuration and Lifecycle Management:
  Advise clients on best practices for configuration management, AI/ML data controls, and other software development processes required by the FDA. You’ll work closely with engineering teams to implement these processes efficiently.
• Project Collaboration:
  Communicate effectively with both software engineers and regulatory professionals, acting as a bridge between technical and compliance teams. You’ll also be involved in planning project timelines, creating detailed meeting agendas, and keeping careful notes to ensure that all regulatory and development milestones are met.

At Innolitics, you’ll be part of a team that is pushing the boundaries of what’s possible in medical device software. Your work will not only meet regulatory standards but also make a real difference in patient care.

• Has a PhD, Masters, or Bachelors in Computer Science, Biomedical Engineering, or a related field.
• Has 3+ years of full-time software engineering experience.
• Is able to code fluently in Python, C++, or Type Script.
• Ideal candidates will also be familiar with web technologies and cloud infrastructure.
• Capable of learning new technologies quickly and independently.
• Wan…