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Medical Device Software Engineer Jobs in Indiana

Eightelevengroup

Software Quality Engineer

Warsaw, IN · On-site

$80 - $100/hr

Software Quality Engineer Warsaw, IN Hybrid role (3 days in office) $55 - $64 per hour ABOUT THE ... Support the design, development, and testing of medical device software, including Software as a ...

Brooksource

Software Quality Engineer

Indianapolis, IN · On-site

$55 - $64/hr

Software Quality Engineer Warsaw, IN Hybrid role (3 days in office) $55 - $64 per hour ABOUT THE ... Support the design, development, and testing of medical device software, including Software as a ...

Jj

Staff Software Engineer - Navigation

Warsaw, IN · On-site

Experience in developing regulated medical device software (SaMD) under standards like IEC 62304 ... Engineering Practices, Software Quality Assurance (SQA), Systems Development Lifecycle (SDLC ...

Collabera

Software Validation Engineer III

Warsaw, IN · On-site

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 ...

Synkriom

Be Seen First

Medical Device Quality Engineer

Warsaw, IN · On-site

$35 - $40/hr

Certified Quality Engineer (CQE) and Medical device, particularly Orthopedic industry, experience preferred Company Description Founded in 2015 and backed by two decades of hands-on experience, our ...

Danaher

Software Engineer Internships

South Bend, IN · On-site

Producing documentation to support medical device regulatory processes Who This Is For * Students graduating in 2026 or later with a Bachelor's degree in Computer Science, Software Engineering ...

Danaher

Software Engineer Internships

Gary, IN

Producing documentation to support medical device regulatory processes Who This Is For * Students graduating in 2026 or later with a Bachelor's degree in Computer Science, Software Engineering ...

Danaher

Producing documentation to support medical device regulatory processes Who This Is For * Students graduating in 2026 or later with a Bachelor's degree in Computer Science, Software Engineering ...

Danaher

Software Engineer Internships

Gary, IN · On-site

Producing documentation to support medical device regulatory processes Who This Is For * Students graduating in 2026 or later with a Bachelor's degree in Computer Science, Software Engineering ...

Danaher

Producing documentation to support medical device regulatory processes Who This Is For * Students graduating in 2026 or later with a Bachelor's degree in Computer Science, Software Engineering ...

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All JobsMedical Device Software Engineer JobsMedical Device Software Engineer Jobs in Indiana

Medical Device Software Engineer information

See Indiana salary details

$60.4K

$140.4K

$195.5K

How much do medical device software engineer jobs pay per year?

As of Sep 9, 2026, the average yearly pay for medical device software engineer in Indiana is $140,378.00, according to ZipRecruiter salary data. Most workers in this role earn between $114,200.00 and $164,600.00 per year, depending on experience, location, and employer.

What is a medical device software engineer?

A Medical Device Software Engineer is responsible for designing, developing, testing, and maintaining software used in medical devices. They ensure compliance with regulatory standards like FDA and IEC 62304 while working on embedded systems, user interfaces, or cloud-based healthcare applications. Their role involves collaborating with cross-functional teams, including hardware engineers and regulatory specialists, to ensure patient safety and product effectiveness.

What are the typical daily responsibilities of a medical device software engineer?

Medical Device Software Engineers typically spend their days designing, coding, and testing software for medical devices in compliance with health regulations. They collaborate closely with hardware engineers, quality assurance teams, and regulatory specialists to ensure that the software integrates seamlessly with device hardware and meets performance and safety standards. Documenting development processes, participating in code reviews, and addressing feedback from cross-functional teams are also common aspects of the role. This position often requires troubleshooting issues in both simulated and real clinical environments to ensure the reliability and safety of the device.

What are the key skills and qualifications needed to thrive as a medical device software engineer?

To thrive as a Medical Device Software Engineer, you need a solid background in software development, embedded systems, and biomedical engineering, often supported by a degree in computer science, electrical engineering, or a related field. Experience with programming languages like C/C++, knowledge of real-time operating systems, and familiarity with medical device regulatory standards such as IEC 62304 are typically required. Strong problem-solving skills, attention to detail, and effective communication are essential soft skills for this position. These skills ensure high-quality, compliant software that contributes to safe and reliable medical devices, which are critical for patient health.

What are the most commonly searched types of Medical Device Software Engineer jobs in Indiana?

The most popular types of Medical Device Software Engineer jobs in Indiana are:

What are popular job titles related to Medical Device Software Engineer jobs in Indiana?

For Medical Device Software Engineer jobs in Indiana, the most frequently searched job titles are:

What job categories do people searching Medical Device Software Engineer jobs in Indiana look for?

The top searched job categories for Medical Device Software Engineer jobs in Indiana are:

Medical Device Software Engineer jobs near you
Infographic showing various Medical Device Software Engineer job openings in Indiana as of September 2026, with employment types broken down into 1% As Needed, 72% Full Time, 22% Part Time, and 5% Contract. Highlights an 90% Physical, 1% Hybrid, and 9% Remote job distribution, with an average salary of $140,378 per year, or $67.5 per hour.

Software Quality Engineer

Warsaw, IN • On-site

Eightelevengroup
See more jobs at Eightelevengroupexternal

$80 - $100/hr

Other

Posted 22 days ago

Key responsibilities

  • Support the design, development, and testing of medical device software, including Software as a Medical Device (SaMD) products

  • Review test case execution results and manage software defects

  • Facilitate software risk assessment sessions and own the development of risk documentation

Job description

Software Quality Engineer

Warsaw, IN

Hybrid role (3 days in office)

$55 - $64 per hour

ABOUT THE ROLE

Join a Fortune 50 Life Sciences company as a Software Quality Engineer, providing quality leadership for a new product project team focused on the development of medical device software systems. In this hybrid role based in Warsaw, IN, you will serve as the subject matter expert in requirements gathering, software risk assessments, test strategy definition, and guiding the team on design controls and defect analysis. You will partner closely with R&D throughout the full development lifecycle—from upstream requirements and risk through mid-stream verification to ongoing compliance and audit readiness. This is a high-visibility opportunity to own quality end-to-end, gain exposure to a full medical device software toolchain, and collaborate cross-functionally with business partners and mentors.

WHAT YOU'LL DO
  • Support the design, development, and testing of medical device software, including Software as a Medical Device (SaMD) products
  • Provide leadership, guidance, and expertise on software development processes, procedures, and practices
  • Serve as a subject matter expert in requirements gathering, test strategy definition, and design controls
  • Facilitate documentation and tracking of verification activities, including code review findings
  • Review test case execution results and manage software defects
  • Facilitate software risk assessment sessions and own the development of risk documentation
  • Support regulatory filings and registrations, including 510(k) submissions and Design History File (DHF) creation
  • Provide technical support for audits of software suppliers and consultants, including cybersecurity and threat modeling topics
  • Conduct training on medical device software development processes and quality systems; develop associated work instructions
  • Provide expertise in applicable industry standards and regulations (e.g., IEC 62304, FDA guidance, FDA Part 11, ISO 13485, EU MDR, ISO 14971, IEC 62366, ISO 27001, HIPAA)
  • Collaborate closely with R&D and cross-functional teams to ensure compliance with industry standards and regulatory requirements
WHAT YOU BRING
  • Bachelor's degree or university degree in Engineering, Computer Science, Information Systems, or Biomedical/Bio-engineering (required)
  • Minimum 4 years of regulated industry experience in quality, new product development, or manufacturing engineering
  • Experience in the medical device industry
  • Proficiency with quality tools, systems, and processes (e.g., Windchill, Polarion, ETQ)
  • Strong interpersonal, organizational, and verbal/written communication skills
  • Ability to work collaboratively in a team environment and demonstrate leadership
  • Ability to perform duties in accordance with company policies, procedures, and civil rights requirements
  • ASQ Certification as a Software Quality Engineer or equivalent (preferred)
  • Expertise in applicable industry standards and regulations (e.g., IEC 62304, FDA guidance, FDA Part 11, ISO 13485, EU MDR, ISO 14971, IEC 62366, ISO 27001, HIPAA)
  • Experience supporting regulatory filings and registrations (e.g., 510(k) submissions, DHF creation)
  • Ability to facilitate software risk assessments and develop risk documentation
WHAT'S IN IT FOR YOU
  • Opportunity to own quality end-to-end on a high-visibility project for a Fortune 50 Life Sciences company
  • Exposure to a full medical device software toolchain (Windchill, Polarion, ETQ) and hands-on involvement
  • Meaningful mentorship scope and cross-collaborative team and business partners
  • Hybrid work environment (3 days in office)
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