Sr. Engineer, Software Dev, R&D

Teleflex • Durham, NC

8d • Onsite

About The Position

As a Senior Engineer specializing in Software, you will advance technological innovations in vascular positioning systems, including artificial intelligence/machine learning (AI/ML), application software, and embedded software systems. This role involves providing software leadership for the development and sustainment of medical device software solutions. You will be responsible for delivering high-quality software solutions that achieve reliable and predictable software releases.

Requirements

• Bachelors Degree in Computer Engineering, Electrical Engineering or equivalent with appropriate experience.
• 6+ years of software development in senior development, preferably with lead role experience, preferably in medical devices or regulated industry, with a proven track record of deployment in commercial products.
• Experience and depth of understanding of modern programming languages (C++ and C#) and design patterns utilized within embedded systems applications.
• Experience developing medical device software within an embedded operating system (such as Linux).
• Experience in creating software solutions 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).
• 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.
• Ability to solve problems for end users, with an ability to translate into software requirements, design, and test specifications.
• 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.
• Excellent verbal and written communication skills.

Nice To Haves

• Comfortable debugging complex integrated systems spanning hardware, embedded, and application software in medical devices.
• Familiarity with ECG monitoring systems and Ultrasound imaging systems.
• Familiarity with Electronic Medical Record (EMR) systems.
• Experience with regulated software incorporating artificial intelligence and machine learning.
• Experience with software development and workflows incorporating AI-based development tools.

Responsibilities

• Lead the development of software for connected medical device software systems, ensuring scalability, reliability, and maintainability.
• Design and develop medical device software that is high quality, safe, secure and compliant.
• Lead software developers, third-party designers, vendors, and contractors to deliver high-quality software solutions.
• Own software design control activities and documentation efforts, including software development planning, software requirements, software risk mitigations, software detailed design, traceability, software reviews, and software releases.
• Ability to deliver software through the entire product development lifecycle, ensuring smooth and efficient operations from initial planning through development, testing, deployment of software features, and software maintenance.
• Comply with Teleflex’s code of Ethics, the company’s Quality System, and all company policies, rules, and housekeeping standards.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior