Innolitics LLC 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 innovative technologies to market. Our team of engineers, consultants, and domain experts works at the intersection of software engineering and regulatory compliance to deliver high-quality solutions. Agentic AI tools like Claude Code and Codex are changing the day-to-day experience of software engineering, and we see this as an opportunity to build robust, traceable, high-quality systems where correctness, safety, and documentation matter. As an engineer here, you will write production code while also developing expertise in medical device regulations, quality systems, verification and validation, and the realities of FDA-facing software. If you’re excited by the intersection of technology, medicine, and regulation, and enjoy organizing and clarifying complex information, you’ll feel at home here.
About the Role:
- Location: Remote (U.S. only)
- Job Type: Full-time
- As a Senior Web/Mobile Medical Device Software Engineer at Innolitics, you will play a cross-functional role in both software development and regulatory projects.
- You will help develop new medical device software, pulling from a strong technical foundation in web technologies and mobile development.
- You will produce technical documentation to support regulatory clearance.
- You will help clients with existing software devices who need to remediate or entirely build out their technical design history file (DHF), in collaboration with our regulatory experts.
Your Responsibilities Will Include:
- Software Development
- Participate in the design and development of new medical device software.
- Write clean, efficient code and ensure it meets both functional requirements and regulatory standards.
- Construct software systems, draft software unit and system tests, and implement robust testing methodologies.
- Cybersecurity
- Guide clients through cybersecurity threat modeling and security risk analysis (with support from internal cybersecurity experts).
- Suggest ways to improve compliance with cybersecurity controls throughout the software development lifecycle.
- Regulatory Compliance
- Collaborate with regulatory professionals to write technical documents in language the FDA understands (e.g., software requirements specifications, software risk assessments, software design specifications).
- Ensure all software documentation complies with FDA guidance.
- System Understanding
- Interview client engineers, review technical documents, and examine source code to build a comprehensive system understanding.
- Help validate that systems are safe and accurately document how they function.
- Configuration and Lifecycle Management
- Advise clients on best practices for configuration management, AI/ML data controls, and other FDA-required software development processes.
- Work with engineering teams to implement these processes efficiently.
- Project Collaboration
- Communicate effectively with software engineers and regulatory professionals, acting as a bridge between technical and compliance teams.
- Help with planning timelines, creating meeting agendas, and keeping careful notes to ensure milestones are met.
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 5+ years of experience in a full-time software engineering role
- Has 3+ years of experience in web technologies
- Has 3+ years of experience in mobile development
- Is able to code fluently in TypeScript and Python
- Is fluent in the use of AI tools as a productivity multiplier
- Is capable of learning new technologies quickly and independently
- Wants to learn about medical devices and FDA regulations
- 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)
- Ideal candidates will also:
- Have familiarity with Swift or Kotlin
- Be familiar with cloud infrastructure and Terraform
- Have experience or interest in learning about cybersecurity
What We Offer
- Competitive base salary: $130,000 to $160,000 (depending on experience)
- 10% performance-based bonus
- Fully remote work with flexible hours
- Comprehensive PTO package
- Partial healthcare reimbursement
- Automatic 3% contribution to a 401(k) retirement plan
- Weekly 10x Time
- Annual company retreat for team building and collaboration
- Mentorship from experienced regulatory and software professionals
- Strong career growth opportunities