Expected Travel: Up to 10%
Requisition ID: 14269
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:
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.
