Pr. Engineer, Software Dev, R&D

Position Summary

As a Principal Engineer specializing in Software, 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, achieving reliable and predictable software market releases.

Principal Responsibilities

•    Create the overall product software architecture for connected medical device software systems, ensuring scalability, reliability, and maintainability.
•    Owns the software development life cycle for connected medical device software systems, ensuring high-quality software is developed that is safe, secure and compliant.
•    Lead software developers, third-party designers, vendors, and contractors to deliver high-quality software solutions. 
•    Lead design control activities and documentation efforts, including requirements, risk assessments and mitigation, traceability, V&V protocols and reports, coding reviews, and software releases.
•    Lead and establish software development best practices within a 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.
•    Comply with Teleflex’s code of Ethics, the company’s Quality System, and all company policies, rules, and housekeeping standards.

Education / Experience Requirements

•    Bachelors 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 industry, with a proven track record of deployment in commercial products.

Specialized Skills / Other Requirements

•    Expertise and depth of understanding of modern programming languages (C++ and C#) and design patterns utilized within embedded systems applications. 
•    Expertise and experience developing medical devices within a Linux environment.
•    Expertise and depth of understanding of creating software architecture for Software in Medical Device (SiMD) and Software as Medical Device (SaMD) software systems.
•    Knowledge and experience with Cybersecurity best practices and Cybersecurity compliance as it pertains to FDA guidance within the development of medical devices.
•    Experience utilizing an Agile software development framework, including Scrum and Continuous Integration/Delivery (CI/CD).
•    Proven experience as a Software Team Leader with the ability to influence and collaborate with key stakeholders and leaders.
•    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-performing 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 (preferred). 
•    Familiarity with ECG monitoring systems and Ultrasound imaging systems (preferred).
•    Experience with regulated software incorporating artificial intelligence and machine learning (preferred).  
•    Experience with software development and workflows incorporating AI-based development tools (preferred).
•    Excellent verbal and written communication skills. 

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Working Conditions / Physical Demands

TRAVEL REQUIRED: <10%

WORKING ENVIRONMENT:
☒ Office/Professional        ☐ Plant/Manufacturing    ☐ Remote/Field     ☐ Laboratory