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.
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.
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 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 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
prahlaad•1h ago
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.
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 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 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