Expected Travel: Up to 10%
Requisition ID: 14010
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:
WORKING ENVIRONMENT:
☒ Office/Professional • Plant/Manufacturing • Remote/Field • Laboratory
At Teleflex, we follow a comprehensive hiring process. We do not accept unsolicited resumes from agency recruiters or 3rd party firms. We do not make unsolicited job offers. We do not ask for money or require equipment purchase up-front.
