Medical Device Software Engineer

About Innolitics 🔗

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.

What you’ll do as a Medical Device Software Engineer at Innolitics 🔗

Client Projects 🔗

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:

  1. Software development projects. You’ll help develop new medical device software.
  2. 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 creating 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.

Your Responsibilities Will Include: 🔗

  • 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.

Who are we looking for? 🔗

Someone who

  • Believes in our mission
  • Shares our values
  • 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 TypeScript
  • Ideal candidates will also be familiar with web-technologies and cloud infrastructure
  • Capable of learning new technologies quickly and independently
  • Wants to learn about medical devices and the FDA regulations that apply to them
  • Is willing to travel a few times a year
  • Can communicate fluently in English via Slack, email, and video calls
  • Lives in the United States (excluding Alaska and Hawaii).

Why would you want to work for us? 🔗

Meaningful work 🔗

We only work on fulfilling projects—ones that we believe improve the world. For example, our current projects include software for radiation oncology clinics, a startup building a medical device to detect ear infections, open-source software used by neurosurgeons and researchers, software for tracking metastatic cancer, and several others. See our portfolio for more examples.

You can see past projects in our portfolio.

Compensation 🔗

The salary for the position is $120k - $130k/year (depending on education and experience), depending on ability and experience. We also have a 10% ($12k - $13k) annual bonus tied to hitting utilization targets.

Financially Stable 🔗

We operate exclusively in the healthcare sector and do not take on debt which shields us from boom and bust economic cycles. We have never had to lay off employees because of a recession.

Tight-knit and growing 🔗

We’re tight-knit, profitable, and growing quickly. If you work with us you can participate in our growth and help define the direction we move in. There will also be opportunities to grow your career. You can also wear many hats and contribute to the company beyond software development.

Talented and fun teammates 🔗

Work with a team of talented, mission-driven engineers who will help you become a better engineer. We're also a lot of fun and have a close-knit group, despite being fully-remote.

Stay relevant 🔗

We invest in the personal and professional development of all our team members. We dedicate two and a half hours on Wednesday afternoons to ongoing learning. Here is a list of our previous learning topics.

You’ll also have opportunities to change projects from time to time and be involved with many more.

Remote only 🔗

We’ve been remote-only since 2012. You can live wherever you want within the United States except for Alaska and Hawaii.

Balance 🔗

We love what we do, but we also have lives outside of work. We have flexible work hours. You are free to work at your own schedule as long as you are not blocked or do not block others. Most individual contributors have an hour worth of meetings a week.

We provide two weeks of paid time off your first year, three weeks your second and third years, and four weeks for each year after that.

Benefits 🔗

We provide a 401(k), with Traditional and Roth options. Innolitics makes an annual contribution, equal to 3% of your salary, to your 401(k) once you’ve worked with us for six months. This contribution vests immediately. The 401(k) plan includes very low-cost index mutual funds, and we cover all the plan costs.

We provide company health insurance (read more about this in our handbook). We reimburse internet costs up to $1200/year and provide a $750/year equipment stipend.

How to Apply 🔗

Fill out your information below.

The cover letter you upload should be three or four short paragraphs explaining why this position in particular interests you and why you are a great fit.

What happens after you apply 🔗

We’ll read your email and review your resume.

If we don’t think you’re a good fit, we’ll let you know. We probably won’t respond if you don’t live in the US or haven’t explained why you want to work at Innolitics in particular.

If it looks like you’re a good fit for the role, we’ll get in touch. The interview process involves a couple of interviews and a take-home activity writing short documents for an imaginary medical device. We'll also require two reference checks.