Katalyst CRO · 4 hours ago
Validation Engineer
Eden Prairie, MN
Contract
Onsite
Senior Level
5+ years expKatalyst CRO is a company focused on providing clinical research services, and they are seeking a Validation Engineer to develop and optimize test cases for design verification strategies. The role involves working closely with the Lead Verification Engineer to validate test methods and support disposables testing, ensuring compliance with quality management standards.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Develop and validate test methods to support disposables testing, including creating test method instructions, validation protocols, and executing validations
Qualify electro-mechanical test tools, fixtures, and software to support defined test methods, including installation and operational qualifications (IQ/OQ)
Perform hands-on testing, analyze data using statistical techniques, and report defects if observed
Participate in root cause investigations and recommend corrective actions
Develop design verification protocols, conduct or oversee their execution, and report results
Organize protocol execution details, ensuring all documentation, materials, and tools are available and under control before execution as part of a Test Readiness Review (TRR)
Estimate task effort and duration, monitor progress, and communicate status updates to stakeholders
Recommend improvements to organizational test and verification SOPs and tools
Adhere to the Quality Management System (QMS), including the development and maintenance of documentation
Qualification
Required
Familiarity with fluid and solid electro-mechanics, and statistics
5+ years of experience in the medical device industry
Experience in 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
Strong problem-solving and analytical skills
Proficiency in Microsoft Office (Outlook, Excel, Word, etc.)
Ability to work on-site
Rigorous mindset and attention to detail
Autonomous and able to work with minimal supervision
Preferred
Bachelor's degree in engineering (Mechanical or a related scientific/technical field is 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 quality system
Knowledge of ISO risk management standard
Experience using requirements and test management tools and Jira for defect tracking
Experience using Minitab for statistical analysis
Strong interpersonal skills and excellent oral and written communication
Experience with Scrum methodology
Team player on internal/external and national/international teams across various disciplines (e.g., systems, hardware, mechanical, quality, regulatory)
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO 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 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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