Medical Software Consultant

Job Title: Medical Software Consultant
Pay Rate: Up to $145 per hour
Location: Remote w/ occasional travel
Job Type: Full Time
Duration: 3-6 months

Position Overview
The Medical Software Consultant is responsible for advising and guiding healthcare organizations on designing and implementing software solutions for medical devices, ensuring compliance with regulatory standards such as 62304, IEC 60601, and FCA Class 2. This role requires a deep understanding of medical device software development, architecture, and regulatory requirements.

Key Responsibilities
*Provide strategic guidance on the design and development of software architectures for medical devices to ensure they meet regulatory standards.
*Collaborate with cross-functional teams including hardware engineers, clinical experts, and quality assurance personnel to align software solutions with organizational goals.
*Advise on compliance with IEC 62304 standards for medical device software lifecycle processes.
*Consult on the implementation and maintenance of systems to comply with IEC 60601 standards for medical electrical equipment safety.
*Guide the management and documentation of software development processes to ensure FCA Class 2 compliance.
*Conduct risk management and mitigation strategies for software development.
*Provide technical guidance and mentorship to junior developers and engineers.
*Stay updated with the latest developments in medical device regulations and standards to offer informed advice.

Qualifications
*Bachelor's or Master's degree in Software Engineering, Computer Science, or related field.
*Proven experience in medical device software development and architecture.
*Extensive knowledge of IEC 62304 standards.
*Strong understanding of IEC 60601 standards.
*Experience with FCA Class 2 requirements and compliance.
*Excellent problem-solving skills and attention to detail.
*Strong communication and collaboration skills.
*Ability to work in a fast-paced, dynamic environment.

Preferred Skills
*Experience with embedded systems and real-time software development.
*Knowledge of medical device risk management frameworks.
*Proficiency in programming languages such as C/C++, Python, or Java.
*Familiarity with software development tools and methodologies.
*Certifications in medical device software development.

Work Environment
This consulting position typically operates in a professional office environment and may require occasional travel to client sites or industry conferences. The Medical Software Architect Consultant will work closely with other engineers, developers, and healthcare professionals to deliver high-quality software solutions that enhance patient care and safety.

EOE/F/M/Disability/Veterans

Build a challenging and rewarding career with an industry leader!