Global Connect Technologies · 1 hour ago
Senior Validation Engineer
Minneapolis, MN
Full-time
Onsite
Senior Level
5+ years expGlobal Connect Technologies is seeking a Senior Verification Engineer responsible for power contrast dye injection system disposables test and verification efforts. This hands-on role involves developing and validating electro-mechanical test methods, executing test cases, analyzing data, and reporting results.
Information Technology & Services
Hiring Manager
Asma Sultana
Responsibilities
Develop and optimize test cases to implement planned design verification strategies set by the Lead Verification Engineer
Develop and validate test methods to support disposables testing. This includes test method instructions, validation protocols, validation execution, and validation reports
Develop and qualify electro-mechanical test tools, fixtures, Software understanding and equipment necessary to support defined test methods. This includes installation and operational qualifications (IQ/OQ)
Perform hands-on testing, analyze data using appropriate statistical techniques, and submit defects if observed. Participate in root cause investigation and recommend corrective actions
Develop design verification protocols, conduct or oversee their execution, and report results
Organize protocol execution details and ensure all documentation, materials, and tools are available and under control prior to execution as part of a Test Readiness Review (TRR)
Estimate task effort and duration, monitor progress, and keep stakeholders up to date with status
Recommend improvements to the organizational test and verification SOPs and tools
Perform work in adherence to the Bracco Medical Technologies (BMT) Quality Management System (QMS), including development and maintenance of documentation
Qualification
Required
Bachelor's degree in engineering (Mechanical or a related scientific/technical field is preferred
Familiar with fluid and solid electro-mechanics, and statistics
5+ years of experience in medical device industry
Experienced with testing disposable medical devices and functional testing of components, assemblies, finished goods and systems, following Good Laboratory Practice
Proven experience in designing V&V test protocols and reports
Experience establishing and maintaining traceability between requirements, test cases, and test results
Rigorous mindset, attention to details
Autonomous, must be able to work with minimal supervision
Microsoft Office (Outlook, Excel, Word, etc.)
Fluent in English
Ability to work on site
Preferred
Master's degree in engineering (Mechanical, Electrical, or a related scientific/technical field is preferred)
Knowledge of medical device regulation 21 CFR 820 and/or ISO 13485 quality system
Knowledge of ISO 14971 risk management standard
Experience using Jama or other requirements and test management tools and Jira for defect tracking
Experience using Minitab for statistical analysis
Strong interpersonal skills, excellent oral and written communication
Team player on internal/external and national/international teams across various disciplines (e.g., systems, hardware, mechanical, quality, regulatory)
Strong problem solving and analytical skills
Experience with Scrum methodology
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