Senior Validation Engineer jobs in United States
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Global Connect Technologies · 1 day ago

Senior Validation Engineer

positionMinneapolis, MN
timeFull-time
remoteOnsite
senioritySenior Level
date5+ years exp

Global Connect Technologies is seeking a Senior Verification Engineer to lead verification efforts for power contrast dye injection system disposables. This hands-on role involves developing and validating electro-mechanical test methods and executing test cases while ensuring compliance with quality management systems.

Information Technology & Services
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H1B Sponsor Likelynote
Hiring Manager
Sushant Banyal
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Responsibilities

Develop and optimize test cases to support design verification strategies
Create and validate test methods for disposables testing, including:
Test method instructions
Validation protocols
Validation execution and reporting
Develop and qualify electro-mechanical test tools, fixtures, and equipment (IQ/OQ)
Perform hands-on testing, analyze data using statistical techniques, and report defects
Support root cause investigations and recommend corrective actions
Develop and execute design verification protocols, and report results
Prepare and manage Test Readiness Reviews (TRR) ensuring documentation, materials, and tools are controlled and available
Estimate task effort and duration, track progress, and communicate status to stakeholders
Recommend improvements to test and verification SOPs and tools
Maintain compliance with Bracco Medical Technologies Quality Management System (QMS) and documentation requirements

Qualification

Medical device testingDesign verification planningElectro-mechanical testingStatistical analysisTest management toolsMedical device regulationsMicrosoft OfficeScrum/Agile methodologyFluent in EnglishCommunication skillsCross-functional teamwork

Required

Bachelor's degree in Engineering (Mechanical or related field preferred)
5+ years of experience in the medical device industry
Strong knowledge of fluid and solid electro-mechanics and statistics
Experience testing disposable medical devices, including functional testing of components, assemblies, and systems
Proven experience designing and executing V&V test protocols and reports
Experience maintaining traceability between requirements, test cases, and test results
Detail-oriented with a rigorous mindset and ability to work independently
Proficient in Microsoft Office (Excel, Word, Outlook)
Fluent in English
Must be able to work on-site in Minneapolis, MN

Preferred

Master's degree in Mechanical, Electrical, or related engineering field
Knowledge of medical device regulations 21 CFR 820 and/or ISO 13485
Familiarity with ISO 14971 risk management
Experience with Jama or other requirements/test management tools, and Jira
Experience using Minitab for statistical analysis
Strong communication and interpersonal skills
Experience working in cross-functional and global teams
Experience with Scrum/Agile methodology

Company

Global Connect Technologies

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Global Connect Technologies is a fast-growing automotive and IT engineering services company based in the USA.
dateFounded in 2022
location
Michigan , US
people-size2-10 employees

H1B Sponsorship

Global Connect Technologies has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (20)
2024 (4)

Funding

Current Stage
Early Stage
Company data provided by crunchbase