Principal Software Engineer - Morrisville, NC

Qualifications
Master’s Degree in Computer Science or equivalent with appropriate experience (Computer Engineering, Electrical Engineering)
12+ years of software development in senior development and lead roles, preferably in medical devices or regulated industries, with a proven track record of deployment in commercial products
Proven experience as SW Team Leader, taking product ideas to market success
Experience in Agile, Azure DevOps, CI/CD, Source Code Management, Verification Automation, Scrum, and software life cycle development in a regulated environment
Experience with medical device regulatory standards such as 21 CFR Part 820, IEC 60601, IEC 62304, and ISO 13485, including experience with system risk, hazard analysis, and DFMEA
Deep commitment to understanding and solving problems for end users, with an ability to translate into software requirements, design, and test specifications
Highly motivated to develop talent, mentor, and build high-performance teams
Track record of strong cross-functional collaboration, influence without authority, and project management, enabling highly effective project teams
Proven self-starter who runs towards critical issues, ambiguous requirements, or loosely defined challenges with a demonstrated ability to rally teams to achieve business results
Comfortable debugging complex integrated systems spanning hardware, embedded, and application software in medical devices
Excellent verbal and written communication skills
Responsibilities
As a Principal Software Engineer, you will lead technological innovations in vascular positioning systems, including artificial intelligence/machine learning (AI/ML), application software, and embedded software systems
This role involves providing strategic cross-functional technical leadership to ensure alignment with best practices and frameworks for delivering high-quality software solutions
You will be responsible for driving software excellence and achieving reliable and predictable software market releases
Create a product software architecture strategy to ensure software systems' scalability, reliability, and maintainability for connected medical systems
Lead design control activities and documentation efforts, including requirements, risk assessments and mitigation, traceability, V&V protocols and reports, coding reviews, and software releases
Establish the best medical device software development practices within the growing business franchise
Oversee the end-to-end delivery process of our applications, ensuring smooth and efficient operations from initial planning through development, testing, and deployment of software features
Manage SW Developers, third-party designers, vendors, and contractors to deliver high-quality engineering solutions
Comply with our code of Ethics, the company’s Quality System, and all company policies, rules, and housekeeping standards
Job description
Principal Software Engineer

As a Principal Software Engineer, you will lead technological innovations in vascular positioning systems, including artificial intelligence/machine learning (AI/ML), application software, and embedded software systems. This role involves providing strategic cross-functional technical leadership to ensure alignment with best practices and frameworks for delivering high-quality software solutions. You will be responsible for driving software excellence and achieving reliable and predictable software market releases.

Principal Responsibilities
• Create a product software architecture strategy to ensure software systems' scalability, reliability, and maintainability for connected medical systems.
• Lead design control activities and documentation efforts, including requirements, risk assessments and mitigation, traceability, V&V protocols and reports, coding reviews, and software releases.
• Establish the best medical device software development practices within the growing business franchise.
• Oversee the end-to-end delivery process of our applications, ensuring smooth and efficient operations from initial planning through development, testing, and deployment of software features.
• Manage SW Developers, third-party designers, vendors, and contractors to deliver high-quality engineering solutions.
• Comply with our code of Ethics, the company’s Quality System, and all company policies, rules, and housekeeping standards
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Education/Requirements
• Master’s Degree in Computer Science or equivalent with appropriate experience (Computer Engineering, Electrical Engineering).
• 12+ years of software development in senior development and lead roles, preferably in medical devices or regulated industries, with a proven track record of deployment in commercial products
• *
• *

Skills
• Proven experience as SW Team Leader, taking product ideas to market success.
• Experience in Agile, Azure DevOps, CI/CD, Source Code Management, Verification Automation, Scrum, and software life cycle development in a regulated environment.
• Experience with medical device regulatory standards such as 21 CFR Part 820, IEC 60601, IEC 62304, and ISO 13485, including experience with system risk, hazard analysis, and DFMEA.
• Deep commitment to understanding and solving problems for end users, with an ability to translate into software requirements, design, and test specifications.
• Highly motivated to develop talent, mentor, and build high-performance teams.
• Track record of strong cross-functional collaboration, influence without authority, and project management, enabling highly effective project teams.
• Proven self-starter who runs towards critical issues, ambiguous requirements, or loosely defined challenges with a demonstrated ability to rally teams to achieve business results.
• Comfortable debugging complex integrated systems spanning hardware, embedded, and application software in medical devices.
• Excellent verbal and written communication skills.