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Medical Device Software Jobs in Indiana (NOW HIRING)

Eightelevengroup

Software Quality Engineer

Warsaw, IN · On-site

$76 - $88/hr

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 ...

Brooksource

Software Quality Engineer

Indianapolis, IN · On-site

$55 - $64/hr

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 ...

BSI Group

Home Based - Global We have exciting opportunities for medical device software specialists to join our Software team. You will have the opportunity to work with medical device manufacturers across ...

BSI Prof Serv EHS West

Home Based - Global We have exciting opportunities for medical device software specialists to join our Software team. You will have the opportunity to work with medical device manufacturers across ...

Flotec

Be Seen First

Customer Service Advocate - Medical Device Manufacturing

Avon, IN · On-site

$40K - $60K/yr

Comfortable working with computers, email, Microsoft Office, and business software systems ... Experience in medical device, healthcare, manufacturing, distribution, or regulated industries.

BSI Prof Serv EHS West

Provide Medical Device QMS assessment and device expertise leadership and mentoring in areas of ... software solutions and cyber security expertise for all industries: from aerospace and automotive ...

BSI Group

Provide Medical Device QMS assessment and device expertise leadership and mentoring in areas of ... software solutions and cyber security expertise for all industries: from aerospace and automotive ...

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 ...

BSI Group

As a Technical Reviewer, you will work with medical device manufacturers throughout their ... software solutions and cyber security expertise for all industries: from aerospace and automotive ...

BSI Prof Serv EHS West

As a Technical Reviewer, you will work with medical device manufacturers throughout their ... software solutions and cyber security expertise for all industries: from aerospace and automotive ...

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Medical Device Software information

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

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 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 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 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:

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

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

Medical Device Software jobs near you
Infographic showing various Medical Device Software job openings in Indiana as of August 2026, with employment types broken down into 1% As Needed, 77% Full Time, 16% Part Time, and 6% Contract. Highlights an 90% Physical, 1% Hybrid, and 9% Remote job distribution.

Software Quality Engineer

Eightelevengroup

Warsaw, IN • On-site

$76 - $88/hr

Other

Posted 15 days ago

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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