Pr. Engineer, Software Dev, R&D

About the role

Vascular & Emergency Medicine - Built on a legacy of innovation and clinical excellence, the Vascular & Emergency Medicine business at Teleflex develops and delivers advanced medical technologies that empower clinicians to help improve patient outcomes and optimize healthcare efficiency. Our trusted Arrow™, Arrow™, EZ-IO™, and QuikClot™ brands set the standard for vascular access and emergency medicine, offering proven solutions to enhance patient outcomes. From technically advanced vascular access devices - including central venous and arterial catheters, PICCs, and sheath introducers with antimicrobial protection-to life-saving intraosseous access systems and hemostatic technologies used by hospitals, EMS, and military teams worldwide, our portfolio embodies precision, reliability, and performance. As part of a high-performing, purpose-driven organization, we are united by a commitment to clinical differentiation, innovation, and excellence. Join a dynamic, growth-focused team that offers advanced medical technology solutions that make a lasting impact on healthcare.

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.

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

• 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).

Qualifications

• Excellent verbal and written communication skills.