Global Connect Technologies · 17 hours ago
Senior Verification Engineer - Medical Devices
Minneapolis, MN
Full-time
Onsite
Senior Level
5+ years expGlobal Connect Technologies is seeking a Senior Verification Engineer to lead test and verification activities for power contrast dye injection system disposables. The role involves developing, validating, and executing electro-mechanical test methods and ensuring compliance with medical device quality and regulatory standards.
Information Technology & Services
Hiring Manager
Bharat Sharma
Responsibilities
Develop and optimize test cases aligned with design verification strategies defined by the Lead Verification Engineer
Develop, validate, and document test methods for disposables testing, including test instructions, validation protocols, execution, and validation reports
Design, develop, qualify, and maintain electro-mechanical test tools, fixtures, software interfaces, and equipment required to support defined test methods, including execution of Installation Qualification (IQ) and Operational Qualification (OQ)
Perform hands-on testing, analyze test data using appropriate statistical techniques, and document results
Identify defects, submit defect reports, participate in root cause investigations, and recommend corrective and preventive actions
Develop design verification protocols, execute or oversee testing activities, and prepare comprehensive verification reports
Organize and manage protocol execution activities, ensuring readiness of documentation, materials, and tools through Test Readiness Reviews (TRRs)
Estimate task effort and timelines, track progress, and provide regular status updates to stakeholders
Recommend and implement improvements to verification processes, SOPs, and testing tools to enhance efficiency and compliance
Perform all work in compliance with the Bracco Medical Technologies (BMT) Quality Management System (QMS), including creation, review, and maintenance of required documentation
Qualification
Required
Bachelor's degree in Engineering (Mechanical or a related scientific/technical field preferred)
Strong understanding of fluid mechanics, solid mechanics, electro-mechanical systems, and statistics
Minimum of 5 years of experience in the medical device industry
Hands-on experience testing disposable medical devices, including functional testing of components, assemblies, finished goods, and systems, in accordance with Good Laboratory Practice (GLP)
Demonstrated experience designing and executing verification and validation (V&V) test protocols and reports
Experience establishing and maintaining traceability between requirements, test cases, and test results
Detail-oriented with a rigorous and quality-focused mindset
Ability to work independently with minimal supervision
Proficiency with Microsoft Office tools (Outlook, Excel, Word)
Fluent in English (written and verbal)
Ability to work on-site as required
Preferred
Master's degree in Engineering (Mechanical, Electrical, or related field)
Knowledge of medical device regulations and standards, including 21 CFR 820 and/or ISO 13485
Familiarity with ISO 14971 risk management processes
Experience using Jama or similar requirements and test management tools, and Jira for defect tracking
Experience with statistical analysis tools such as Minitab
Strong interpersonal, written, and verbal communication skills
Proven ability to collaborate effectively with cross-functional teams, including systems, hardware, mechanical, quality, and regulatory teams across global locations
Strong analytical and problem-solving capabilities
Experience working within Agile or Scrum development environments
Company
Global Connect Technologies
Global Connect Technologies is a fast-growing automotive and IT engineering services company based in the USA.
Founded in 2022Michigan , US
2-10 employeesH1B 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 StageCompany data provided by crunchbase