Link: <https://innolitics.com/join/senior-web-mobile-medical-device-engineer/>
Senior Web/Mobile Medical Device Engineer
Location: Remote (U.S. only)
Job Type: Full-time
About Us
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. 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.
As an engineer here, you will not only write production code, but also develop
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
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, and
you will produce technical documentation to support regulatory clearance.
Additionally, you will help clients with existing software devices who need to
remediate or entirely build out their technical design history file,
leveraging deep technical expertise and client communication skills to produce
a thorough, accurate representation of the software for regulatory submission—
in collaboration with our team of regulatory experts.
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 5+ years of experience in a full-time professional software engineering
role
Has 3+ years of experience in a full-time web- or mobile-development role
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 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)
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 - $160,000 depending on experience
10% performance-based bonus
Fully remote work with flexible hours
Comprehensive PTO package
Partial healthcare reimbursement and 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
How to Apply
Fill out your information using the form on the link below.
Please, provide a cover letter (4–5 short paragraphs) explaining why this role
interests you and why you’re a good fit.
Link: <https://innolitics.com/join/senior-web-mobile-medical-device-engineer/>