Software Engineer

Job Title: Senior Software Engineer (Medical Device Software)

Location: Remote (United States)

Employment Type: Contract (W2)

Duration: 12+ Months

Rate: $30–$35 per hour (W2)

This pay range represents a good-faith estimate of the compensation for this role at the time of posting. Actual compensation may vary based on factors such as experience, education, and relevant skill set, and will comply with applicable federal, state, and local wage laws.

Benefits: This is a contract position. No employer-provided benefits are offered unless otherwise specified by the client.

Job Summary

We are seeking an experienced Senior Software Engineer to support the design, development, enhancement, and maintenance of medical device software products. The ideal candidate will have hands-on experience developing software for regulated medical devices and a strong understanding of software development lifecycle processes, design controls, and quality requirements.

In this role, you will design and implement software solutions for both new and existing products while contributing to software infrastructure, automated testing frameworks, build and deployment pipelines, and cloud-connected technologies. You will collaborate closely with cross-functional teams including Systems Engineering, Quality, Regulatory Affairs, Product Development, and Verification & Validation to ensure compliance, product performance, and patient safety.

Responsibilities

• Design, develop, test, debug, and maintain software for medical device products throughout the product lifecycle.
• Develop software in compliance with medical device regulations and industry standards, including design controls and software development best practices.
• Participate in software architecture, detailed design, implementation, and code reviews.
• Support software build systems, CI/CD pipelines, automated testing frameworks, and development tools.
• Collaborate with systems, hardware, quality, and regulatory teams to ensure software requirements are accurately implemented and verified.
• Troubleshoot software defects and perform root cause analysis for product and development issues.
• Develop and maintain software documentation including requirements, design specifications, test protocols, and traceability artifacts.
• Contribute to risk management activities, software hazard analysis, and cybersecurity initiatives as applicable.
• Support verification and validation activities, including unit testing, integration testing, and system-level testing.
• Participate in design reviews and provide technical input for product improvements and new technology initiatives.
• Assist with software remediation, maintenance releases, and post-market product support activities.
• Ensure compliance with applicable FDA regulations, IEC standards, and internal quality management system requirements.

Required Qualifications

• Bachelor’s degree in Computer Science, Software Engineering, Computer Engineering, Electrical Engineering, or a related technical discipline.
• 5+ years of software development experience, including experience developing software for medical devices or other regulated products.
• Demonstrated experience with embedded software, device software, or product software development for medical devices.
• Strong understanding of software development lifecycle (SDLC) methodologies and design control requirements.
• Experience with object-oriented programming and modern software development practices.
• Experience with software debugging, troubleshooting, and defect resolution.
• Knowledge of software verification and validation methodologies.
• Experience working in cross-functional product development environments.
• Strong written and verbal communication skills.

Preferred Qualifications

• Experience with FDA-regulated medical device software development.
• Familiarity with IEC 62304, ISO 14971, FDA Design Controls, and software quality standards.
• Experience with automated testing frameworks and continuous integration/continuous deployment (CI/CD) tools.
• Experience supporting cloud-connected or internet-enabled medical device solutions.
• Knowledge of cybersecurity requirements for medical devices.
• Experience with Agile development methodologies.

Work Requirements

• Ability to work remotely within the United States.
• Ability to participate in virtual meetings and collaborate across multiple time zones.
• Occasional travel may be required for project meetings, testing activities, or team collaboration sessions.
• Ability to work independently while effectively contributing to a distributed team environment.

Equal Opportunity Employer

We are an Equal Opportunity Employer and consider all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, or any other characteristic protected by applicable law.

Application

Qualified candidates with medical device software development experience are encouraged to apply. Please submit your resume highlighting relevant software engineering experience, regulated industry experience, and technical expertise related to medical device product development.