1

Manager Medical Device Software Engineer Jobs (NOW HIRING)

The Software Engineer Manager will also help bring biotechnology software development capabilities ... Manage software development activities throughout the complete medical device product lifecycle ...

The Software Engineer Manager will also help bring biotechnology software development capabilities ... Manage software development activities throughout the complete medical device product lifecycle ...

Senior Software Engineer

San Diego, CA

$130K - $171K/yr

As medical device development is iterative and subject to regulatory, technical, and business ... and risk management - Experience supporting FDA submissions or audits - Bilingual in English and ...

Director, Software Engineering

Irvine, CA ยท Hybrid

$223K - $260K/yr

... management skills with experience leading software organizations and external software engineer contractors. * Familiarity with cloud-connected medical device systems, mobile applications ...

Senior Software Engineer

San Diego, CA ยท On-site

$130K - $171K/yr

As medical device development is iterative and subject to regulatory, technical, and business ... and risk management - Experience supporting FDA submissions or audits - Bilingual in English and ...

Software Architect - Medical Device

Bedford, MA ยท On-site

$200K - $220K/yr

... software engineering experience. * Hands-on & Architecture: Active proficiency in C++, Java ... Position Summary Reporting to the Software Manager for Architecture and Platforms, you will own the ...

Senior Software Engineer

Scottsdale, AZ ยท On-site

$123K - $163K/yr

... release management practices. Basic Qualifications: Education: * Bachelor's degree in software ... Experience * 7+ years of experience in software engineering, with experience in medical device or ...

Medical Device Engineer

Aurora, CO ยท Hybrid

$57.69/hr

Support risk management activities in accordance with ISO 14971 methodologies. * Participate in ... Embedded systems, power electronics, or medical device software integration experience. * Direct ...

Principal, Software Engineer

Lake Forest, CA ยท On-site

$143K - $192K/yr

Systems Engineering or Risk Management for Medical Device (ISO 14971) * Medical Device Software - Software Life Cycle Processes (IEC 62304) * Regulations and Guidelines associated with software ...

next page

Showing results 1-20

Manager Medical Device Software Engineer information

See salary details

$99.5K

$169.4K

$200.5K

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

As of Aug 5, 2026, the average yearly pay for manager medical device software engineer in the United States is $169,381.00, according to ZipRecruiter salary data. Most workers in this role earn between $173,000.00 and $173,000.00 per year, depending on experience, location, and employer.

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.

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 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.
More about Manager Medical Device Software Engineer jobs
What cities are hiring for Manager Medical Device Software Engineer jobs? Cities with the most Manager Medical Device Software Engineer job openings:
What are the most commonly searched types of Medical Device Software Engineer jobs? The most popular types of Medical Device Software Engineer jobs are:
What states have the most Manager Medical Device Software Engineer jobs? States with the most job openings for Manager Medical Device Software Engineer jobs include:
Infographic showing various Manager Medical Device Software Engineer job openings in the United States as of July 2026, with employment types broken down into 77% Full Time, 14% Part Time, and 9% Contract. Highlights an 92% Physical, 2% Hybrid, and 6% Remote job distribution, with an average salary of $169,381 per year, or $81.4 per hour.

Quality Engineer with Medical device

Kappium LLC

Warsaw, IN โ€ข On-site

Other

Posted 2 days ago

New


Job description

 Start date: 24-Aug-2026  

Location: Warsaw, Indiana (hybrid role โ€“ 3 days onsite)

Duration: 9-12 months, extensions highly likely

Job:   Quality (software)  for Medical Device software 

Software Quality Engineer โ€“ Medical Device Software Development

Job Summary

The Software Quality Engineer will provide quality leadership on cross-functional product development teams responsible for developing regulated medical device software systems. This individual will serve as a subject matter expert in software quality, requirements management, software risk management, verification and validation strategy, design controls, and defect management throughout the software development lifecycle.

Key Responsibilities

  • Support the design, development, verification, and validation of regulated medical device software, including Software as a Medical Device (SaMD).
  • Provide technical leadership and guidance on software development processes, quality systems, and best practices.
  • Partner with engineering teams to refine software requirements and ensure architecture and design documentation is complete and compliant.
  • Facilitate documentation and tracking of software verification activities, including code review findings and testing results.
  • Review software test execution results, manage software defects, and support root cause investigations.
  • Lead software risk assessment activities and develop software risk management documentation.
  • Support regulatory submissions, product registrations, and compliance documentation.
  • Support internal and external quality audits and regulatory inspections related to software products and quality systems.
  • Manage nonconformances, CAPAs, and corrective actions associated with software development activities.
  • Provide technical support for software supplier and third-party software development audits.
  • Deliver training on software development processes, quality systems, and applicable regulatory requirements.
  • Mentor junior engineers and provide guidance on software quality engineering best practices.
  • Ensure compliance with applicable software and medical device standards, including:
    • IEC 62304
    • ISO 13485
    • ISO 14971
    • IEC 62366
    • FDA Software Guidance
    • FDA 21 CFR Part 11
    • EU MDR
    • ISO 27001
    • HIPAA
  • Ensure software products meet cybersecurity, privacy, electronic protected health information (ePHI), and personally identifiable information (PII) protection requirements.
  • Collaborate with cross-functional teams to ensure compliance with company quality systems, policies, and applicable regulatory requirements.
  • Communicate project risks, quality issues, and opportunities to leadership as appropriate.
  • Follow all health, safety, environmental, and quality procedures.
  • Perform additional responsibilities as assigned.

Education & Experience

  • Bachelorโ€™s degree in Engineering, Computer Science, Information Systems, Biomedical Engineering, or a related technical discipline required.
  • Minimum of four years of experience in a regulated industry within software quality, quality engineering, new product development, or manufacturing engineering.
  • Experience supporting software development within a regulated medical device environment.
  • Demonstrated understanding of software quality systems, design controls, software verification and validation, and risk management.
  • Experience applying quality tools, processes, and methodologies to support product development.

Required Skills & Qualifications

  • Strong understanding of the medical device software development lifecycle.
  • Experience with Software as a Medical Device (SaMD) development preferred.
  • Knowledge of software risk management, design controls, software verification and validation, defect management, and CAPA processes.
  • Familiarity with FDA and international medical device regulations and standards.
  • Strong analytical, organizational, and problem-solving skills.
  • Excellent written and verbal communication skills.
  • Ability to work effectively on cross-functional engineering teams.
  • Proficiency with Microsoft Office applications, including Word, Excel, and PowerPoint.
  • ASQ Certified Software Quality Engineer (CSQE) or equivalent certification is preferred.