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Manager Medical Device Software Engineer Jobs (NOW HIRING)

Nova Biomedical

Software Engineer Manager

Norwood, MA · On-site

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

Diality

Director, Software Engineering

Irvine, CA · 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 ...

Diality Inc

Director, Software Engineering

Irvine, CA · On-site

$223K - $260K/yr

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

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

Ziehm Orthoscan

Senior Software Engineer

Scottsdale, AZ · On-site

$123K - $162K/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 ...

Inuson International, Inc.

senior software engineer

Durham, NC · On-site

$118K - $156K/yr

Roles and Responsibilities Quickly learn relevant knowledge and skills specific to medical device ... Configuration management, source control, and issue tracking tools. Virtualization. Database design.

Alcon

Principal, Software Engineer

Lake Forest, CA · 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 ...

Teleflex

Sr. Engineer, Software Dev, R&D

Morrisville, NC · On-site

$114K - $151K/yr

... Engineer specializing in Software, you will advance technological innovations in vascular ... Principal Responsibilities • Lead the development of software for connected medical device ...

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Manager Medical Device Software Engineer information

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$99.5K

$169.4K

$200.5K

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

As of Aug 26, 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 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.
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Manager Medical Device Software Engineer jobs near you
Infographic showing various Manager Medical Device Software Engineer job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 77% Full Time, 15% Part Time, and 7% Contract. Highlights an 89% Physical, 1% Hybrid, and 10% Remote job distribution, with an average salary of $169,381 per year, or $81.4 per hour.

Software Design Control Engineer

San Francisco, CA • On-site

Jobtailor
See more jobs at Jobtailorexternal

$130 - $190/hr

Other

Posted 7 days ago

Job description

  • Work alongside software engineers to author, review, and maintain comprehensive design control documentation, including Software Requirements Specifications, Architecture & Design Documents, and Traceability Matrices.
  • Ensure software development processes align with IEC 62304 (Medical Device Software Lifecycle), ISO 13485, and FDA 21 CFR Part 820 regulations.
  • Author and maintain software risk management files, including Software FMEAs per ISO 14971.
  • Produce software verification and validation (V&V) protocols and reports in coordination with the engineering and test teams to ensure full traceability.
  • Compile and organize necessary software technical documentation for regulatory submissions.
  • Maintain and update software documentation for post-market surveillance, CAPAs, and software updates.
Requirements
  • 5+ years of experience in the medical device industry, specifically working with software‑driven or connected medical devices (Class II or Class III).
  • A Bachelor’s degree in Computer Science, Biomedical Engineering, Software Engineering, or a related field, or equivalent practical engineering experience.
  • Demonstrated experience writing, reviewing, and managing formal medical device software documentation (Design History Files, Traceability Matrices).
  • Proven track record of taking a medical device software product through a successful FDA clearance/approval process and subsequent launch.
  • Deep familiarity with IEC 62304, ISO 14971, and FDA Software Validation Guidelines.
  • Experience with modern software development workflows (e.g. Git, Jira) and quality system tools (e.g. Greenlight Guru, Arena, Matrix Requirements, or Jama).
Core Competencies

Expertise in authoring and managing medical device software documentation, including compliance with IEC 62304, ISO 14971, and FDA regulations. Proven ability to navigate the FDA clearance process for software‑driven medical devices.

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