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Contract Medical Device Software Engineer Jobs (NOW HIRING)

Cesna Group

Senior Software Engineer

San Diego, CA · On-site

$100K - $200K/yr

We are seeking a Senior Software Engineer to play a key role in maintaining, evolving, and ... As medical device development is iterative and subject to regulatory, technical, and business ...

Spruce Infotech

Software Engineer C++

Arden Hills, MN · On-site

... medical device systems. Work with a team of highly skilled engineers to deliver groundbreaking ... Develop software for testing platforms and complex software tools. * Integrate software designs ...

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Contract Medical Device Software Engineer information

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$63.5K

$147.5K

$205.5K

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

As of Jul 15, 2026, the average yearly pay for contract medical device software engineer in the United States is $147,524.00, according to ZipRecruiter salary data. Most workers in this role earn between $120,000.00 and $173,000.00 per year, depending on experience, location, and employer.

What are some common challenges faced by Contract Medical Device Software Engineers, and how can they be addressed?

Contract Medical Device Software Engineers often encounter the challenge of rapidly adapting to new projects, technologies, and regulatory requirements unique to each client. Working within strict timelines while ensuring compliance with FDA and ISO standards can be demanding. To address these challenges, it's important to have strong communication skills, maintain thorough documentation, and stay updated on industry regulations. Collaborating closely with cross-functional teams—including quality assurance, hardware engineers, and regulatory affairs—also helps ensure project success and smooth integration into existing workflows.

What is the difference between Contract Medical Device Software Engineer vs Medical Device Software Developer?

AspectContract Medical Device Software EngineerMedical Device Software Developer
CredentialsTypically requires a degree in software engineering, biomedical engineering, or related field; certifications like ISO 13485 or FDA compliance knowledge are commonSimilar educational background; often holds certifications in medical device regulations or quality standards
Work EnvironmentContract roles in medical device companies, often project-based, with focus on compliance and validationFull-time or freelance positions within medical device firms, focusing on software development and testing
Industry UsageCommonly hired for specific projects requiring regulatory compliance and validation expertiseInvolved in ongoing software development, maintenance, and updates for medical devices

While both roles require technical expertise in medical device software, Contract Medical Device Software Engineers typically work on short-term projects with a focus on compliance and validation, whereas Medical Device Software Developers are involved in continuous software development and maintenance within the industry.

What is a Contract Medical Device Software Engineer?

A Contract Medical Device Software Engineer is a software professional who is hired on a temporary or project basis to design, develop, and test software used in medical devices. They typically work with manufacturers to ensure that the software meets regulatory standards, such as those set by the FDA or ISO. Responsibilities may include creating embedded software, documenting code, and collaborating with cross-functional teams to deliver safe and effective medical products. Their expertise is crucial for developing reliable software that supports patient safety and product compliance.

What are the key skills and qualifications needed to thrive as a Contract Medical Device Software Engineer, and why are they important?

To thrive as a Contract Medical Device Software Engineer, you need a solid background in software development (C/C++/Python), embedded systems, and knowledge of medical device regulations such as IEC 62304, typically supported by a relevant engineering degree. Familiarity with development environments, version control (e.g., Git), and tools for requirements management and verification are essential, along with any certifications in medical device software or quality systems. Strong problem-solving skills, attention to detail, and effective communication are crucial for collaborating with cross-functional teams and ensuring regulatory compliance. These skills and qualifications are vital to deliver safe, compliant, and innovative software solutions efficiently in a highly regulated and dynamic industry.
What cities are hiring for Contract Medical Device Software Engineer jobs? Cities with the most Contract 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 Contract Medical Device Software Engineer jobs? States with the most job openings for Contract Medical Device Software Engineer jobs include:
Contract Medical Device Software Engineer jobs near you
Design Quality Engineer, Software Medical Device

Design Quality Engineer, Software Medical Device

Senseye

Austin, TX • On-site

$100K - $125K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Re-posted 2 days ago

Job description

About Us
Senseye is a NeuroTechnology Company in Austin, TX on the cusp of revolutionizing Mental Health. Over the past 6 years we have invested millions of dollars in R&D to build our platform allowing us to measure cognitive activity via the eye through mobile phones. Through multiple iterations and use cases we are now focused on building the world's first Objective Mental Health Diagnostics on top of our core technology. Our first diagnostic is for PTSD and is entering clinical trials now, followed soon by additional indications for Anxiety and Depression. As the world struggles with a mental health crisis, it is not hyperbolic to suggest that an objective diagnostic platform, that gives clinicians a safe and objective accurate approach to identifying and monitoring mental health disease, will redefine how mental health services are provided and will enable access to treatment for hundreds of millions of sufferers. The Senseye platform has the potential to be the technology that drives this change.
Senseye is developing AI-enabled software medical devices to help make mental health assessment more objective, starting with PTSD. We are looking for a Design Quality Engineer for our software medical device (SaMD) who can partner closely with engineering, clinical, regulatory, and product teams to build practical, audit-ready quality processes for SaMD development.
Role Description
This is a hands-on role for someone who understands design controls, software lifecycle documentation, risk management, and regulated product development - and who wants to help shape the quality system rather than simply maintain one. This is an intersection role: it requires both medical-device design-controls/quality experience and hands-on software / SaMD lifecycle experience - not one or the other.
Requirements
This role requires both of the following, not either/or:
  • 4+ years in medical-device design quality, design assurance, or quality engineering for regulated software (design controls + software lifecycle).
  • 2+ years hands-on with SaMD, SiMD, or medical-device software (including digital health / diagnostics software).
  • Hands-on experience with design controls, risk management, software validation, traceability, and quality-system documentation.
  • Working knowledge of ISO 13485, ISO 14971, IEC 62304, FDA QMSR / 21 CFR Part 820, and 21 CFR Part 11.
  • Comfort working directly with software teams using tools such as Jira, GitHub, Confluence, and eQMS systems.

Responsibilities
  • Own and improve SaMD design-control deliverables, including user needs, design inputs/outputs, traceability, design reviews, verification/validation evidence, and DHF readiness.
  • Partner with software, data science, clinical, and regulatory teams to apply IEC 62304, ISO 14971, ISO 13485:2016, FDA QMSR / 21 CFR Part 820, and applicable software quality practices.
  • Support AI/ML model lifecycle quality practices, including documentation, risk controls, change control, validation evidence, and total-product-lifecycle thinking.
  • Help define pragmatic QMS processes for a fast-moving regulated startup, including software development, non-product software validation / CSA, supplier controls, CAPA, and audit readiness.
  • Contribute to cybersecurity, usability/HFE, post-market, complaint, and quality-metrics activities in partnership with subject-matter experts
Nice to Have
  • AI/ML-enabled medical-device experience.
  • Familiarity with IMDRF GMLP principles.
  • Cybersecurity documentation experience for medical devices.
  • Usability / human factors engineering experience.
  • FDA submission, audit, notified-body, CAPA, or post-market experience.
  • Experience in a startup or early-stage regulated product environment.

Why this role is compelling
You will help shape the quality foundation for an AI-enabled SaMD product, not just maintain inherited procedures.
  • You will work cross-functionally with engineering, clinical, regulatory, product, and data science teams.
  • You will have direct impact on design controls, software lifecycle quality, risk management, and audit readiness.
  • You will join at a stage where quality decisions still materially shape how the product and QMS scale.

Benefits
  • The freedom and trust to define your role as we design, build, and ship our products
  • Competitive salary and stock option plan
  • Flexible paid time off (vacation, sick leave, and public holidays)
  • Flexible schedules
  • Company health care plan
    • Medical, dental, and vision insurance
    • Short and long term disability insurance
    • Life insurance policy
  • 401k
  • Commuter benefits for parking, public transit, carshares, etc.
  • Mothers' room
  • Fully stocked kitchen
  • Opportunities for continuing education

The compensation for this role is $100,000 - $125,000 annually.
Senseye is dedicated to building a community of employees that are diverse, passionate, and engaged. We are committed to equal opportunity regardless of race, color, ancestry, religion, gender, gender identity, parental or pregnancy status, national origin, sexual orientation, age, marital status, disability, or veteran status. When we're safe, healthy, and balanced we can accomplish phenomenal things together.
Senseye logo

About Senseye

Sourced by ZipRecruiter

Industry

Scientific research and development services

Company size

11 - 50 Employees

Headquarters location

Austin, TX, US

Year founded

2015

Social media

Twitter

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