| Validation Systems Engineer ||Onsite||NC||USC,GC||Local|| at Raleigh, North Carolina, USA |
| Email: [email protected] |
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http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=2963891&uid=e66a97ddf7d246a19d9d9f9cace44fe6 Job Title: Sr. Principal Engineer (medical devices) Location: Onsite Raleigh NC Contract: 12+ months contract with extension Job Description Summary: Job Description Senior Principal Systems Engineer (Software) Infusion Pump Platforms Overview This role focuses on developing and sustaining software for Infusion Pump medical devices , delivering high-quality healthcare solutions that meet regulatory standards. You will lead system-level software engineering activities, guide cross-functional teams, and ensure compliance with medical device development processes. Key Responsibilities Lead best practices for software systems development and lifecycle management. Provide technical leadership, mentorship, and review of engineering work. Develop solutions for complex software system challenges under tight timelines. Translate user needs (Clinical/Commercial) into system-level requirements. Decompose system requirements into software subsystem requirements. Lead software-related risk analysis (hazards mitigations). Define verification & validation strategies using requirements traceability. Participate in software design reviews. Support Agile planning: estimation, scheduling, backlog maintenance. Drive collaboration with internal and external stakeholders. Ensure compliance with quality systems and design control. Support design transfer to manufacturing, service, customer training. Top Skills & Must-Haves 10+ years Engineering experience (Systems or Software Engineering). Strong systems engineering background (requirements, architecture, decomposition). Experience with electro-mechanical devices (highly preferred). Hands-on medical device / regulated industry experience (preferably FDA 21 CFR 820, ISO 13485). Experience in Agile development, backlog creation/management. Expertise in risk management (FMEA, hazard analysis, risk controls). Strong verification & validation planning, test strategies, traceability. Excellent documentation, communication, cross-functional leadership. Experience supporting design transfer, manufacturing & service functions. Preferred Experience Infusion pumps, drug delivery systems, or other Class II/III medical devices. Software development background (embedded software, digital health apps). Working with cross-functional teams: clinical, commercial, regulatory, QA. Thanks & Regards Varun Bhardwaj Senior Technical Recruiter Vyze Software Solutions Pvt Ltd Email [email protected] Contact 5716807043 Hangout ID [email protected] -- Keywords: quality analyst information technology Idaho North Carolina Validation Systems Engineer ||Onsite||NC||USC,GC||Local|| [email protected] http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=2963891&uid=e66a97ddf7d246a19d9d9f9cace44fe6 |
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| 11:46 PM 02-Dec-25 |