Would you be interested in being responsible for upgrading software processes and procedures, within medical compliance and coding best practices, including AI assessment?

We are on a HOT search for our client who needs a Sr. Software Engineer to perform as a Technical Lead. The successful candidate will have a minimum of 10 years experience in Medical Device.

Needed is someone with maturity and deep technical chops as both a coder and tester, and strong regulatory knowledge with both Med Dev software and documentation.

Given this job’s function, this role has a strong impact on the quality of products, operational efficiency, and compliance with regulations.

This role is open due to expansion and growth.

POSITION SUMMARY:

Design, develop, and implement new software for medical products that meets user requirements. Perform and manage creation of software specifications, design and development of application software products, firmware of products, and production software tools. Create and write software code with focus on fault-tolerant programming. Define and implement test methods for performance, verification and validation testing of new and existing software systems. Provide ongoing maintenance, support and enhancements to existing software systems and platforms. Analyze and troubleshoot field reported software issues to create and implement corrective actions.

PRIMARY (Essential) FUNCTIONS:

1 Provide technical expertise in the development of product and application software.

• Provide recommendations and technical guidance on software system designs, platforms, and architecture to meet new market and customer needs.
• Collaborate cross functionally with others in software development planning, design approaches/or new technologies using best practices.
• Create software requirement specifications based on user requirements and product design requirements.
• Write new software and firmware code that reliably functions and performs in accordance with the software requirement specifications.
• Create and perform manual and automated software bug testing and code reviews to ensure software quality prior to release.
• Develop test methodologies protocols, and perform software debugging, unit testing, and integration testing to ensure compatibility, reliability, and stability.
• Create software design documents, flowcharts, and other design output documentations for software and firmware to support product maintenance and verification testing.
• Create and maintain trace matrices and provide support for software audit and regulatory submissions as required for all software and firmware related products.
• Develop and perform test protocols for product software validation testing.
• Select and manage external resources for software validation testing and cybersecurity penetration testing.
• Develop and implement improved procedures and methodologies for software development in compliance with medical device regulations and with consideration for current software best practices.
• May develop or maintain software for website products, or direct external resources.

2 Perform sustaining activities for field reported issues with existing firmware and software products.

• Actively participate in investigations of issues related to software systems.
• Perform or recommend appropriate analysis of field reported issues related to software or firmware performance.
• Implement or recommend appropriate corrective actions to existing software or firmware to address field reported issues.
• Develop new or modify existing software and firmware code to reduce field reported issues.
• Analyze and create software and firmware testing methods including regression testing to ensure compatibility, reliability, and stability.
• Update and maintain changes to trace matrices and related documentation for all modifications to software and firmware related products.

OTHER FUNCTIONS: Other duties as assigned.

QUALIFICATIONS:

Education / Training / Certifications / Licenses:

Bachelor’s Degree in Software Engineering or Computer Science.

Experience:

• Ten or more years of experience in software development after Bachelor’s degree.
• Of those ten years, five or more years must have been in the medical device industry.
• At least two years’ experience developing and testing real-time firmware for actively controlling medical devices with electro-mechanical elements such as motors and valves.
• Experience in cybersecurity is necessary.
• Although this position is an individual contributor engineer, prior experience as a people manager or project manager is desirable.
• Experience developing code for web sites is desirable.

Skills/Abilities:

• Demonstrated ability to apply problem-solving techniques to achieve positive results.
• Proficiency using code management and version control tools such as Git, Mercurial, SVN.
• Proficiency in programing languages such as C#, C, C++, SQL.
• Working knowledge of serial communications standards such as RS-232, RS-485, USB. SPI.
• Working knowledge of software IDEs such as Microsoft Visual Studio, Microchip MPLAB X, etc.
• Strong knowledge of medical device safety and software standards such as IEC 60601, IEC 62304, ISO 14971.
• Working knowledge of medical IT infrastructure, cybersecurity requirements, and compliance.
• Ability to work with multi-disciplinary teams at both domestic and international locations.
• Proficiency in standard Microsoft office computer applications.

Salary: $150K-180K, DOE