Staff Medical Device Software Engineer

Innolitics; Northern (KY); Remote; USD 170,000 - 200,000; Full time

Benefits offered by this job

401(k) plan with company contributions

Health insurance

Internet reimbursement up to $1,200/yr

Equipment stipend $750/yr

Job summary

Innolitics, a remote-first medical device software firm, seeks a Staff Medical Device Software Engineer who has shipped regulated software. You will lead client projects from design control through FDA submissions, write code for SaMD, and review development plans against IEC 62304.

You will draft software descriptions for 510(k), De Novo, and PMA; perform threat modeling and cybersecurity risk analysis; and mentor teams while leveraging AI coding tools daily. Remote work across the US.

Qualifications

• Minimum 10+ years in a full-time software engineering role.
• Direct involvement in at least one FDA submission that cleared or was approved.
• Experience shipping regulated medical device software.

Responsibilities

• Design and build SaMD and AI/ML device software with clean, tested code.
• Write FDA software documentation: requirements, architecture, risk analysis, verification plans/reports, cybersecurity docs.
• Set up and audit IEC 62304 and ISO 13485 software processes.
• Prepare software sections of 510(k), De Novo and PMA submissions; respond to FDA deficiency letters.
• Lead client meetings and track milestones.
• Use AI coding and drafting tools daily to multiply output.

Skills

Python

C++

TypeScript

AI tools

Regulatory understanding

Education

PhD in CS/Biomedical Engineering or related

Masters in CS/Biomedical Engineering or related

Bachelors in CS/Biomedical Engineering or related

Tools

Terraform

Job description

Staff Medical Device Software Engineer

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

Job Type: Full-time

About Us

Innolitics is a remote-first company specializing in medical device software development and FDA regulatory consulting. Since 2012, we've partnered with medical device companies to bring new technologies to market. Our team of engineers, consultants, and domain experts works at the intersection of software engineering and regulatory compliance.

Agentic AI tools like Claude Code and Codex are changing the day-to-day experience of software engineering. We see this as an opportunity, not a threat. We are a growing, collaborative team that is actively learning how to use these tools to produce robust, traceable, high-quality systems where correctness, safety, and documentation matter.

About the role

We are hiring a staff engineer who has already shipped regulated medical device software. You will lead client projects from design control through submission. On a typical week you will write code for a new SaMD product, review a client's software development plan against IEC 62304, draft a software description for a 510(k), and explain to a client's CEO why a change requires a new submission. You will be the person in the room who understands both the code and the regulation.

What you’ll do

• Design and build SaMD and AI/ML device software with clean, tested code.
• Write FDA software documentation: software requirements, architecture, risk analysis under ISO 14971, verification plans and reports, cybersecurity documentation.
• Set up and audit clients' IEC 62304 and ISO 13485 software processes.
• Prepare software sections of 510(k), De Novo and PMA submissions and Pre-Submissions. Answer FDA deficiency letters.
• Run threat modeling and cybersecurity risk analysis.
• Lead client meetings, set project plans and track milestones.
• Use AI coding and drafting tools daily. We expect them to multiply your output, not replace your judgment.

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 10+ years of experience in a full-time software engineering role
• Had direct involvement in at least one FDA submission that cleared or was approved.
• Is able to code fluently in Python, C++, or TypeScript
• Is fluent in the use of AI tools as a productivity multiplier
• Is capable of learning new technologies quickly and independently
• Wants to continue learning about medical devices and the FDA regulations that apply to them
• Is willing to travel 2-3 times a year (client visits and our annual retreat)
• Can communicate fluently in English via Slack, email, and video calls
• Lives in the United States (excluding Alaska and Hawaii)

Experience with ISO 14971, IEC 62366, FDA cybersecurity guidance, AI/ML PCCPs, or cloud infrastructure with Terraform is a plus.

Why would you want to work for us?

Meaningful work

We only take on projects we believe improve the world. Recent projects include software for radiation oncology clinics, a device that detects ear infections, open-source software used by neurosurgeons and researchers, an AI cardiomegaly detector that went from concept to FDA clearance in under 12 months, and software for tracking metastatic cancer. See our portfolio for more.

Compensation

The salary for the position is $170,000-$200,000/year, depending on education and experience. We also have a 10%-12% annual bonus tied to hitting billing 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. You can 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 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 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.

Remote only

We've been remote-only since 2012, so we know how to run a remote company effectively. You can live anywhere in the United States except Alaska and Hawaii.

Benefits

We provide a 401(k) with Traditional and Roth options. Innolitics contributes 3% of your salary annually once you've worked with us for six months, vesting immediately. The plan includes very low-cost index funds and we cover all plan costs.

We provide company health insurance ( details in our handbook ). We reimburse internet costs up to $1,200/year and provide a $750/year equipment stipend.