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Medical Device Software Jobs in Indiana (NOW HIRING)

The Software Validation Engineer will be responsible for performing validation activities as new or ... Medical device experiences a plus. Other regulated environment experience is a plus. Additional ...

Producing documentation to support medical device regulatory processes Who This Is For * Students graduating in 2025 or later with a Bachelor's degree in Computer Science, Software Engineering ...

Producing documentation to support medical device regulatory processes Who This Is For * Students graduating in 2025 or later with a Bachelor's degree in Computer Science, Software Engineering ...

Producing documentation to support medical device regulatory processes Who This Is For * Students graduating in 2025 or later with a Bachelor's degree in Computer Science, Software Engineering ...

Producing documentation to support medical device regulatory processes Who This Is For * Students graduating in 2025 or later with a Bachelor's degree in Computer Science, Software Engineering ...

Producing documentation to support medical device regulatory processes Who This Is For * Students graduating in 2025 or later with a Bachelor's degree in Computer Science, Software Engineering ...

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Medical Device Software information

What are the key skills and qualifications needed to thrive as a Medical Device Software Engineer, and why are they important?

To thrive as a Medical Device Software Engineer, you need strong programming abilities (often in C/C++ or Python), a solid understanding of software development life cycles, and familiarity with medical device regulations, typically backed by a degree in computer science, engineering, or a related field. Experience with development tools, embedded systems, and compliance standards like IEC 62304 or FDA requirements is highly valued. Attention to detail, problem-solving, and effective teamwork are essential soft skills in this role. These competencies ensure the creation of reliable, safe, and regulatory-compliant software critical for patient health and device performance.

What is the difference between Medical Device Software vs Medical Device Quality Assurance Specialist?

AspectMedical Device SoftwareMedical Device Quality Assurance Specialist
Required CredentialsSoftware development certifications, engineering degrees, FDA regulations knowledgeQuality assurance certifications (e.g., CQE), regulatory compliance training
Work EnvironmentSoftware development teams, R&D labs, regulatory agenciesManufacturing facilities, quality assurance labs, regulatory bodies
Employer & Industry UsageMedical device manufacturers, software firms in healthcareMedical device manufacturers, healthcare companies, regulatory agencies
Common Search & ComparisonFocuses on software development and complianceFocuses on quality processes and regulatory adherence

Medical Device Software professionals develop and maintain software used in medical devices, ensuring functionality and compliance. Medical Device Quality Assurance Specialists focus on testing, validation, and ensuring products meet quality standards. Both roles are essential in the medical device industry but differ in their core responsibilities and skill sets.

What are some common challenges faced by professionals working in Medical Device Software development?

Professionals in Medical Device Software development often navigate complex regulatory requirements, such as FDA or ISO standards, which can impact project timelines and processes. Collaborating closely with cross-functional teams—including hardware engineers, clinicians, and quality assurance specialists—is essential to ensure safety and compliance. Additionally, balancing innovation with rigorous documentation and validation can be challenging, as even minor software changes may require extensive testing and approval. Staying updated with evolving cybersecurity standards is also a key part of the role.

What is medical device software?

Medical device software is specialized software designed to be used for medical purposes, such as diagnosing, preventing, monitoring, or treating health conditions. It can be embedded within a medical device (like a pacemaker) or function as standalone software (such as mobile health apps). This software must comply with strict regulatory standards to ensure safety and effectiveness, as it directly impacts patient health and safety. Developers of medical device software must follow guidelines from authorities like the FDA or EU MDR, depending on the market. Regular updates, risk management, and comprehensive testing are also essential parts of its development process.
What are popular job titles related to Medical Device Software jobs in Indiana? For Medical Device Software jobs in Indiana, the most frequently searched job titles are:
Infographic showing various Medical Device Software job openings in Indiana as of May 2026, with employment types broken down into 3% Locum Tenens, 1% Internship, 1% As Needed, 37% Full Time, 11% Part Time, and 47% Contract. Highlights an 92% Physical, 2% Hybrid, and 6% Remote job distribution.
Senior Software Engineer for Medical Device Startup

Senior Software Engineer for Medical Device Startup

Levisonics, Inc.

Fishers, IN • On-site

$115K - $152K/yr

Full-time

Medical, Dental, Vision, PTO

Posted 17 days ago


Job description

About Us:
We are a dynamic and innovative medical device startup developing a point-of-care portable blood coagulation testing device. Our full-time team currently comprises a CEO/Biomedical Engineer, and an Electrical Engineer.
Job Summary:
We are seeking a talented and experienced Senior Software Engineer to join our team and lead the development and optimization of software workflows for our innovative acoustic tweezing technology-based medical devices. The ideal candidate will have a Master's degree in Computer Science, Software Engineering, or a related field, with a minimum of 5 years of experience. This role requires strong coding skills in Python and C/C++, proficiency in developing intuitive and visually engaging graphical user interfaces, and expertise in SQL for effective data management and database design. Experience with version control systems, particularly Git, is essential, along with the ability to understand and generate code from workflow diagrams. As the first and only software engineer on the team, you will play a pivotal role in shaping the software development efforts for our groundbreaking technology. This role is critical to the success of our product and involves working on multiple federal grants and projects.
Startup Environment:
We operate in a fast-paced startup environment where innovation, adaptability, and a proactive mindset are key to success. We are looking for individuals who are passionate about working in a startup setting and thrive in dynamic and challenging situations. We value individuals who are not just seeking a job but are driven by a genuine passion for creating impactful solutions and driving change in the medical device industry. Our team members are expected to work well under pressure, juggle multiple projects, and be flexible in their roles as the needs of the company evolve. If you are excited about the opportunity to make a meaningful impact and are ready to roll up your sleeves and tackle challenges head-on, we encourage you to apply.
Key Responsibilities:
  1. Optimize and Enhance Existing Software:
  • Improve the efficiency of our existing software written in Python.
  • Increase processing speed for short-term operation on laptops.
  • Convert and optimize the software for embedded computing devices inside the medical device long-term.
  1. Software Packaging and Security:
  • Secure the code to prevent reverse engineering.
  • Package the software into executable files for easy installation and deployment.
  1. Connectivity and Data Management:
  • Ensure the software can connect to the internet.
  • Implement connectivity to an online database for long-term data management.
  • Incorporate Data Science, Machine Learning, and AI for handling large amounts of health data.
  1. Health Data Security:
  • Ensure the highest level of security for software and health data management.
  1. New Technique Development:
  • Convert and develop existing crude MATLAB codes and technology algorithms into efficient software for commercial use.
  • Create executable files with efficient large data handling capabilities.
  • Develop complex data processing software and manage large data analysis.
  • Develop a user-friendly interface for healthcare professionals.
  • Implement a remote kill switch for the software.
  • Apply all relevant requirements from existing software.
  1. Parallel Processing and Language Conversion:
  • Implement efficient parallel processing techniques.
  • Convert existing Python code to C/C++ or another suitable low-level efficient language to run software optimally on embedded hardware.
  1. Other Responsibilities:
  • Develop high-quality, efficient, and maintainable code.
  • Design intuitive and visually engaging user interfaces.
  • Proactively take on new responsibilities and suggest innovative ideas for product and company growth.
  • Participate in grant writing and fundraising activities.
  • Engage in FDA-related activities and adhere to quality protocols.
  • Perform other relevant software-related tasks as needed for the company.

Minimum Qualifications:
  • Master's degree in Computer Science, Software Engineering, or a related field.
  • Minimum of 5 years of experience in software development.
  • Strong coding skills in Python, C, and C++ (JavaScript is a plus).
  • Proficiency in developing intuitive and visually engaging graphical user interfaces.
  • Proficiency in SQL for effective data management and database design.
  • Experience with version control systems, particularly Git.
  • Ability to understand and generate code from workflow diagrams.
  • Knowledge of integrating multiple devices and establishing centralized control.
  • Familiarity with IDEs, preferably PyCharm.
  • Excellent problem-solving skills and ability to work independently.
  • Strong written and verbal communication skills.

Preferred Qualifications:
  • Experience working in the medical device industry.
  • Familiarity with Agile development methodologies.
  • Knowledge of machine learning techniques and algorithms.
  • Experience with Docker and containerization technologies.
  • Familiarity with cloud platforms such as AWS or Azure.
  • Prior experience working in startups.
  • Experience with embedded systems and medical device software development.
  • Strong knowledge of data security, especially related to health data.
  • Knowledge of parallel processing and algorithm optimization.
  • Innovative mindset with a track record of proactive contributions.
  • Experience in grant writing and regulatory compliance (FDA).

What We Offer:
  • Competitive salary
  • Health, dental, and vision insurance coverage
  • Generous paid time off
  • Professional development opportunities
  • Potential to receive stock options
  • Opportunities for growth within the company
  • Flexible work arrangements, including remote work options
  • Dynamic and innovative startup environment
  • Opportunity to make a meaningful impact in the medical device industry