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Medical Device Software Jobs (NOW HIRING)

Diality

Director, Software Engineering

Irvine, CA · Hybrid

$223K - $260K/yr

Description Company & Job Overview Diality is a medical device company focused on developing ... The Director of Software Engineering reports to Director of Product Development and leads Diality ...

Diality Inc

Director, Software Engineering

Irvine, CA · On-site

$223K - $260K/yr

Company & Job Overview Diality is a medical device company focused on developing solutions to ... The Director of Software Engineering reports to Director of Product Development and leads Diality ...

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 ...

Suntra MedTech Solutions

Software Architect

Bedford, NH · On-site

Responsible for the high-level architecture and design of medical device software, ensuring alignment with system and software requirements. This "hands-on" role requires you to be in our Bedford, NH ...

Actalent

Medical Device Engineer

Aurora, CO · Hybrid

$57.69/hr

Embedded systems, power electronics, or medical device software integration experience. * Direct interaction with Notified Bodies or third-party compliance laboratories. Technologies & Standards You ...

Abbott

Software Quality Engineer

Alameda, CA · On-site

$80 - $85/hr

Review quality system documentation products as they apply to the development, verification, validation, use, and maintenance of medical device software. Coordinate activities with other engineering ...

AbbVie

Device Software Engineer

Irvine, CA · On-site

$109K/yr

... medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across ... software development background in a structured/regulated environment such as medical device ...

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Medical Device Software information

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How much do medical device software jobs pay per hour?

As of Aug 10, 2026, the average hourly pay for medical device software in the United States is $49.84, according to ZipRecruiter salary data. Most workers in this role earn between $35.10 and $59.62 per hour, depending on experience, location, and employer.

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 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.

Is medical device software a good career?

Medical device software is a growing field that involves developing and maintaining software for medical equipment, requiring knowledge of regulatory standards like FDA and ISO. It offers opportunities in healthcare technology, often requiring skills in programming, testing, and compliance, with a stable job outlook due to increasing healthcare needs. Professionals in this area can work in multidisciplinary teams and may need certifications such as ISO 13485 or IEC 62304.

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 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.
More about Medical Device Software jobs
What cities are hiring for Medical Device Software jobs? Cities with the most Medical Device Software job openings:
What states have the most Medical Device Software jobs? States with the most job openings for Medical Device Software jobs include:
What job categories do people searching Medical Device Software jobs look for? The top searched job categories for Medical Device Software jobs are:
Medical Device Software jobs near you
Infographic showing various Medical Device Software job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 78% Full Time, 15% Part Time, and 6% Contract. Highlights an 96% Physical, 1% Hybrid, and 3% Remote job distribution, with an average salary of $103,662 per year, or $49.8 per hour.

Design Software Quality Consultant (Medical Devices)

Stark Pharma Solutions Inc

Piscataway, NJ • Remote

Contractor

Re-posted 10 days ago

Job description

Hi,

My name is Karthik Mutyala, from Stark Pharma Solutions Inc, we are hiring talents for our client. I am working on Design Software Quality position right now. Please send me your updated resume if you have relevant experience and interested in this position. The detailed job description is as follows

Role: Design Software Quality Consultant (Medical Devices)

Location: REMOTE
Duration: Long Term
 

Position Overview

We are seeking an experienced Design Software Quality Consultant to support post-acquisition integration activities for a medical device product portfolio. This role will focus on ensuring software design quality, regulatory compliance, and successful integration of acquired products into the client's quality management system.

The ideal candidate will have deep expertise in Software Design Quality, Model-Based Systems Engineering (MBSE), and medical device software compliance, with experience supporting new product development in regulated environments.

Key Responsibilities

  • Review and assess Design History Files (DHFs) and product development documentation for acquired medical device products.
  • Support software design quality activities during post-acquisition product integration.
  • Ensure compliance with internal quality standards and global regulatory requirements.
  • Lead Model-Based Systems Engineering (MBSE) activities for software-enabled medical devices.
  • Review software engineering deliverables to ensure compliance with design controls and quality requirements.
  • Partner with cross-functional teams including R&D, Software Engineering, Quality, and Regulatory Affairs.
  • Support risk management, usability engineering, and software lifecycle compliance activities.

Required Qualifications

  • 10+ years of Software Quality Engineering experience in the medical device industry.
  • Strong experience with Software Design Quality and Design Controls.
  • Hands-on experience with Model-Based Systems Engineering (MBSE).
  • Experience supporting software quality for new product development or medical device integration/remediation projects.
  • Knowledge of IEC 62304, IEC 60601, ISO 14971, and medical device software regulations.
  • Experience with Software as a Medical Device (SaMD).
  • Strong understanding of software verification, validation, and compliance within regulated environments.

I am actively connecting with professionals for current and upcoming opportunities. If you are open to exploring new roles or would like to stay informed about relevant positions, please send me your updated resume along with the best number and time to reach you.  

Please follow Stark Pharma Solutions on LinkedIn for the latest job updates: https://www.linkedin.com/company/99455976/

Thank you,

Karthik Mutyala

Recruiting Manager

Stark Pharma Solutions Inc

Email: karthik@starkpharma.com

15 Corporate Place S, Suite 350,

Piscataway, New Jersey 08854

www.starkpharma.com