Sr. Engineer, Software Dev, R&D

Position Summary

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.

Principal 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 lifecyle, 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.

Education / Experience 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.

Specialized Skills / Other Requirements

•    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.
•    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).
•    Familiarity with Electronic Medical Record (EMR) 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. 

Working Conditions / Physical Demands

TRAVEL REQUIRED: <10%

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