Teleflex Incorporated is seeking a Senior Engineer specializing in Software to implement technological innovations in vascular positioning systems, including artificial intelligence/machine learning (AI/ML), application software, and embedded software systems, to improve the health and quality of people’s lives.
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.
- Hands-on experience with multiple operating systems (Windows, iOS, Android), scripting and programming languages (PowerShell, C-Sharp), 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).
- 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.
- Comfortable debugging complex integrated systems spanning hardware, embedded, and application software in medical devices (preferred).
Responsibilities
- Designs, develops, verifies, and maintains medical device software following industry best practices, ensuring scalability, reliability, and maintainability of software systems for connected medical systems.
- Partakes in design control activities and documentation efforts, including requirements, risk assessments and mitigation, traceability, V&V protocols and reports, coding reviews, and software releases.
- Collaborates with stakeholders, third-party designers, vendors, and contractors to deliver high-quality engineering solutions.
- Participates in risk assessments and failure mode analysis (FMEA) to identify and mitigate potential risks.
- Comfortable with all layers of full-stack development and verification of medical devices, while ensuring compliance with all relevant regulations.
- Defines, develops, and maintains automation at all levels of the software stack as it relates to DevOps, release management, and CI/CD pipelines.
- Participates in all SDLC activities and maintains relevant, accurate and complete documentation.
Other
- Up to 10% travel required.
- Master’s Degree in Computer Science or equivalent with appropriate experience.
- 8+ years of software development in senior development or lead roles.
- Highly motivated to share knowledge and mentor others.
- Excellent verbal and written communication skills.
