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Senior Verification Engineer
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Senior Verification Engineer
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cGxPServe Get AI-powered advice on this job and more exclusive features. Manual Protocol Tester to support software verification activities for web-based applications integrated with heart failure/ medical devices. The ideal candidate will have hands-on experience in protocol-based testing, medical device software verification, and compliance with regulatory standards.
Job Description
Manual Protocol Tester to support software verification activities for web-based applications integrated with heart failure/ medical devices. The ideal candidate will have hands-on experience in protocol-based testing, medical device software verification, and compliance with regulatory standards.
Responsibilities:
Execute manual protocol-based testing for web applications supporting heart failure device workflows. Review and validate software requirements, design specifications, and protocol documents. Develop and maintain test protocols, test cases, and test reports in alignment with regulatory standards. Perform functional, integration, regression, and system-level testing based on approved protocols. Develop and maintain test cases using tools like PTC or equivalent. Document and manage defects using tools like JIRA or equivalent. Ensure traceability between requirements, protocols, and test results. Collaborate with cross-functional teams including R&D, Quality Assurance, and Regulatory Affairs. Support verification and validation (V&V) activities and contribute to design history file (DHF) documentation. Ensure testing activities comply with FDA standards.
Requirements:
Bachelor's degree in engineering, Computer Science, Biomedical Engineering, or related field. Minimum 5 years of experience in manual protocol-based testing and within the medical device industry is plus. Strong understanding of web application testing and clinical workflows related to heart failure management. Experience with protocol writing, execution, and documentation in a regulated environment. Familiarity with regression analysis, risk management, traceability matrices, and compliance documentation. Excellent communication and analytical skills. Medical class II or class III is a must. Strong communication and presentation skills is a must. IEC medical standards is a must. Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Quality Assurance Industries Research Services Referrals increase your chances of interviewing at cGxPServe by 2x Sign in to set job alerts for “Senior Validation Engineer” roles.
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Senior Verification Engineer
role at
cGxPServe 2 days ago Be among the first 25 applicants Join to apply for the
Senior Verification Engineer
role at
cGxPServe Get AI-powered advice on this job and more exclusive features. Manual Protocol Tester to support software verification activities for web-based applications integrated with heart failure/ medical devices. The ideal candidate will have hands-on experience in protocol-based testing, medical device software verification, and compliance with regulatory standards.
Job Description
Manual Protocol Tester to support software verification activities for web-based applications integrated with heart failure/ medical devices. The ideal candidate will have hands-on experience in protocol-based testing, medical device software verification, and compliance with regulatory standards.
Responsibilities:
Execute manual protocol-based testing for web applications supporting heart failure device workflows. Review and validate software requirements, design specifications, and protocol documents. Develop and maintain test protocols, test cases, and test reports in alignment with regulatory standards. Perform functional, integration, regression, and system-level testing based on approved protocols. Develop and maintain test cases using tools like PTC or equivalent. Document and manage defects using tools like JIRA or equivalent. Ensure traceability between requirements, protocols, and test results. Collaborate with cross-functional teams including R&D, Quality Assurance, and Regulatory Affairs. Support verification and validation (V&V) activities and contribute to design history file (DHF) documentation. Ensure testing activities comply with FDA standards.
Requirements:
Bachelor's degree in engineering, Computer Science, Biomedical Engineering, or related field. Minimum 5 years of experience in manual protocol-based testing and within the medical device industry is plus. Strong understanding of web application testing and clinical workflows related to heart failure management. Experience with protocol writing, execution, and documentation in a regulated environment. Familiarity with regression analysis, risk management, traceability matrices, and compliance documentation. Excellent communication and analytical skills. Medical class II or class III is a must. Strong communication and presentation skills is a must. IEC medical standards is a must. Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Quality Assurance Industries Research Services Referrals increase your chances of interviewing at cGxPServe by 2x Sign in to set job alerts for “Senior Validation Engineer” roles.
Pleasanton, CA $86,700.00-$173,300.00 2 weeks ago Medical Device Senior Quality Engineer (Electromechanical)
Alameda, CA $125,000.00-$175,000.00 3 weeks ago San Jose, CA $170,000.00-$210,000.00 4 days ago Alameda, CA $125,000.00-$175,000.00 6 days ago Quality Assurance Quality Control Engineer
Senior Quality Engineer - Multiport Da Vinci (Systems Design Control and Risk Management)
Sunnyvale, CA $126,100.00-$213,500.00 2 weeks ago Senior Software Quality Engineer, Post Market
Senior Software Quality and Compliance Engineer - AD/ADAS Systems
Sr. Quality Engineer - Multiport Da Vinci Instruments
Sunnyvale, CA $126,100.00-$213,500.00 5 days ago Senior Systems Engineer, Fleet Validation Lead
Mountain View, CA $167,200.00-$303,050.00 2 weeks ago Manager, Systems Verification & Validation, Platform Safety Assurance
Foster City, CA $189,000.00-$238,000.00 2 weeks ago Santa Clara, CA $125,000.00-$255,000.00 1 hour ago Principal Hardware Engineer - Quality & Reliability
San Jose, CA $225,000.00-$325,300.00 6 days ago Engineering Manager, Chassis Quality & Validation
San Jose, CA $108,000.00-$135,000.00 3 weeks ago Validation Engineering Manager - SerDes, PCIe
San Jose, CA $200,000.00-$270,000.00 3 days ago Sr. Software Engineer, HIL Automation, Autonomy
Sr. Flight Software Engineer (Verification)
Mountain View, CA $185,000.00-$230,000.00 1 week ago Union City, CA $135,000.00-$205,000.00 11 hours ago Sr. SDE, WorkSpaces Control Plane, Amazon WorkSpaces
Santa Clara, CA $151,300.00-$261,500.00 3 days ago Senior Backend Software Engineer, TikTok Customer Service Platform
San Jose, CA $187,040.00-$359,720.00 7 hours ago Palo Alto, CA $136,000.00-$204,000.00 2 weeks ago Mountain View, CA $153,000.00-$222,000.00 1 week ago Senior Software Engineer, Autonomy - Simulation, Vehicle Dynamics Modeling
Mountain View, CA $198,000.00-$216,000.00 2 weeks ago Senior Frontend Software Engineer - TikTok Effect House
San Jose, CA $187,040.00-$359,720.00 7 hours ago Redwood City, CA $140,000.00-$198,000.00 4 days ago Senior Security Software Architect - Security Engineering - San Jose
San Jose, CA $257,400.00-$616,000.00 4 weeks ago Santa Clara, CA $140,000.00-$150,000.00 6 days ago San Jose, CA $160,000.00-$210,000.00 6 days ago Senior Test and Validation Engineer, Drive Unit Test and Validation
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr