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Manager Medical Device Software Engineer Jobs in Indiana

Eightelevengroup

Software Quality Engineer

Warsaw, IN · On-site

$80 - $100/hr

Support the design, development, and testing of medical device software, including Software as a ... Review test case execution results and manage software defects * Facilitate software risk ...

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 ... Review test case execution results and manage software defects * Facilitate software risk ...

Jj

Staff Software Engineer - Navigation

Warsaw, IN · On-site

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

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

We are seeking engineers with SaMD (Software as a Medical device) in technical capacity which can include product design, development and/or testing. Purpose of the position To build, manage, develop ...

BSI Prof Serv EHS West

We are seeking engineers with SaMD (Software as a Medical device) in technical capacity which can include product design, development and/or testing. Purpose of the position To build, manage, develop ...

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 ...

Actalent

Medical Device Packaging Engineer

Warsaw, IN

$34 - $44/hr

... a project leader or manager. Responsibilities * Design products for manufacturability ... Engineering required. * 0-1 years of experience required. * Experience within the medical device ...

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 ...

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Manager Medical Device Software Engineer information

What does a manager medical device software engineer do?

A Manager Medical Device Software Engineer oversees teams that design, develop, and maintain software for medical devices. They ensure that the software complies with regulatory standards, works reliably, and meets the needs of healthcare professionals and patients. In addition to technical leadership, they coordinate with cross-functional teams, manage project timelines, and mentor engineers. Their role is critical in ensuring products are both safe and effective for use in medical settings.

How does a manager medical device software engineer typically collaborate with cross-functional teams during product development?

A Manager Medical Device Software Engineer frequently works alongside teams such as regulatory affairs, quality assurance, hardware engineering, clinical specialists, and marketing. They coordinate software development activities to ensure compliance with industry standards and regulatory requirements, while also aligning software features with clinical and business needs. These managers often lead design reviews, facilitate risk assessments, and ensure effective communication between software engineers and non-technical stakeholders. This collaborative environment is essential for delivering safe, effective, and user-friendly medical devices.

What are the key skills and qualifications needed to thrive as a manager medical device software engineer, and why are they important?

To thrive as a Manager Medical Device Software Engineer, you need expertise in software development, medical device regulations (such as FDA or ISO 13485), and a background in engineering or computer science, often supported by advanced degrees or certifications. Familiarity with tools like version control systems (e.g., Git), embedded systems platforms, and quality management software is essential, along with understanding regulatory documentation processes. Strong leadership, effective communication, and problem-solving abilities distinguish top performers in this role. These skills are crucial for ensuring safe, compliant, and innovative medical device software development while leading teams to deliver high-quality products.

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 Manager Medical Device Software Engineer jobs in Indiana?

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

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

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

What cities in Indiana are hiring for Manager Medical Device Software Engineer jobs?

Cities in Indiana with the most Manager Medical Device Software Engineer job openings:

Manager Medical Device Software Engineer jobs near you

Software Quality Engineer

Eightelevengroup

Warsaw, IN • On-site

$80 - $100/hr

Other

Posted 21 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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