Teleflex
Senior Engineer, Software Development
Teleflex, Morrisville, North Carolina, United States, 27560
As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people’s lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. Teleflex is the home of Arrow™, Barrigel™, Deknatel™, LMA™, Pilling™, QuikClot™, Rüsch™, UroLift™ and Weck™ – trusted brands united by a common sense of purpose. At Teleflex, we are empowering the future of healthcare.
Vascular Access –
Built on a history of innovation, our Arrow™ brand of technically advanced vascular access devices are renowned throughout the world. Many of our vascular access products have antimicrobial and antithrombogenic protection designed to reduce vascular‑related complications and include long and short dwell central venous catheters (CVC), sheath introducers, arterial lines, peripherally inserted central catheters (PICC), as well as specialty devices and an advanced vascular positioning system to facilitate precise placement of a PICC or CVC near the heart.
Position Summary As a Senior Engineer specializing in Software, you will be instrumental in implementing 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 reinforcing software excellence and achieving reliable and predictable software market releases.
Responsibilities
Design, develop, verify, and maintain medical device software following industry best practices, ensuring scalability, reliability, and maintainability of software systems for connected medical systems.
Participate in design control activities and documentation efforts, including requirements, risk assessments and mitigation, traceability, V&V protocols and reports, coding reviews, and software releases.
Collaborate with stakeholders, third‑party designers, vendors, and contractors to deliver high‑quality engineering solutions.
Participate in risk assessments and failure mode analysis (FMEA) to identify and mitigate potential risks.
Be comfortable with all layers of full‑stack development and verification of medical devices, while ensuring compliance with all relevant regulations.
Define, develop, and maintain automation at all levels of the software stack as it relates to DevOps, release management, and CI/CD pipelines.
Participate in all SDLC activities and maintain relevant, accurate, and complete documentation.
Comply with Teleflex’s code of Ethics, the company’s Quality System, and all company policies, rules, and housekeeping standards.
Education / Experience Requirements
Master’s Degree in Computer Science or equivalent with appropriate experience (Computer Engineering, Electrical Engineering).
8+ years of software development in senior development or lead roles, preferably in medical devices or regulated industry, with experience in deployment of commercial products.
Highly motivated to share knowledge and mentor others.
Hands‑on experience with multiple operating systems (Windows, iOS, Android), scripting and programming languages (PowerShell, C#), programming paradigms (OO, concurrent, declarative), cloud computing (Azure), YAML, Azure DevOps, CI/CD, SCM, Git, Verification Automation, Agile, Scrum, and SDLC preferably in a regulated environment (medical devices, automotive, aviation).
Specialized Skills / Other Requirements
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.
Track record of cross‑functional collaboration, influence without authority, and project management, enabling highly effective project teams.
Self‑starter who runs towards critical issues, ambiguous requirements, or loosely defined challenges with the hands‑on technical ability to tackle them.
Comfortable debugging complex integrated systems spanning hardware, embedded, and application software in medical devices (preferred).
Excellent verbal and written communication skills.
Self‑motivated to work independently and efficiently in a team‑oriented environment.
Promotes and fosters positive behavior and work environment.
Critical thinking, attention to detail, and problem‑solving skills, including identifying, recommending, and implementing solutions.
Results‑oriented with strong analytical skills, exercises appropriate judgment, and makes decisions based on accurate and timely information.
Possesses high integrity and dependability with a strong work ethic.
Working Conditions / Physical Demands TRAVEL REQUIRED: 5 %
Equal Opportunity Employment Teleflex Incorporated is an equal‑opportunity employer. Applicants will be considered without regard to age, race, religion, color, national origin, ancestry, sexual orientation, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: 877‑880‑8588 or Talent@Teleflex.com.
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Vascular Access –
Built on a history of innovation, our Arrow™ brand of technically advanced vascular access devices are renowned throughout the world. Many of our vascular access products have antimicrobial and antithrombogenic protection designed to reduce vascular‑related complications and include long and short dwell central venous catheters (CVC), sheath introducers, arterial lines, peripherally inserted central catheters (PICC), as well as specialty devices and an advanced vascular positioning system to facilitate precise placement of a PICC or CVC near the heart.
Position Summary As a Senior Engineer specializing in Software, you will be instrumental in implementing 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 reinforcing software excellence and achieving reliable and predictable software market releases.
Responsibilities
Design, develop, verify, and maintain medical device software following industry best practices, ensuring scalability, reliability, and maintainability of software systems for connected medical systems.
Participate in design control activities and documentation efforts, including requirements, risk assessments and mitigation, traceability, V&V protocols and reports, coding reviews, and software releases.
Collaborate with stakeholders, third‑party designers, vendors, and contractors to deliver high‑quality engineering solutions.
Participate in risk assessments and failure mode analysis (FMEA) to identify and mitigate potential risks.
Be comfortable with all layers of full‑stack development and verification of medical devices, while ensuring compliance with all relevant regulations.
Define, develop, and maintain automation at all levels of the software stack as it relates to DevOps, release management, and CI/CD pipelines.
Participate in all SDLC activities and maintain relevant, accurate, and complete documentation.
Comply with Teleflex’s code of Ethics, the company’s Quality System, and all company policies, rules, and housekeeping standards.
Education / Experience Requirements
Master’s Degree in Computer Science or equivalent with appropriate experience (Computer Engineering, Electrical Engineering).
8+ years of software development in senior development or lead roles, preferably in medical devices or regulated industry, with experience in deployment of commercial products.
Highly motivated to share knowledge and mentor others.
Hands‑on experience with multiple operating systems (Windows, iOS, Android), scripting and programming languages (PowerShell, C#), programming paradigms (OO, concurrent, declarative), cloud computing (Azure), YAML, Azure DevOps, CI/CD, SCM, Git, Verification Automation, Agile, Scrum, and SDLC preferably in a regulated environment (medical devices, automotive, aviation).
Specialized Skills / Other Requirements
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.
Track record of cross‑functional collaboration, influence without authority, and project management, enabling highly effective project teams.
Self‑starter who runs towards critical issues, ambiguous requirements, or loosely defined challenges with the hands‑on technical ability to tackle them.
Comfortable debugging complex integrated systems spanning hardware, embedded, and application software in medical devices (preferred).
Excellent verbal and written communication skills.
Self‑motivated to work independently and efficiently in a team‑oriented environment.
Promotes and fosters positive behavior and work environment.
Critical thinking, attention to detail, and problem‑solving skills, including identifying, recommending, and implementing solutions.
Results‑oriented with strong analytical skills, exercises appropriate judgment, and makes decisions based on accurate and timely information.
Possesses high integrity and dependability with a strong work ethic.
Working Conditions / Physical Demands TRAVEL REQUIRED: 5 %
Equal Opportunity Employment Teleflex Incorporated is an equal‑opportunity employer. Applicants will be considered without regard to age, race, religion, color, national origin, ancestry, sexual orientation, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: 877‑880‑8588 or Talent@Teleflex.com.
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