Validation Engineer

Eden Prairie, MN, US • Posted 26 days ago • Updated 10 hours ago

Full Time

On-site

Fitment

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Job Details

Skills

Test Methods
IQ
OQ
ROOT
Management
Reporting
Quality Management
QMS
Documentation
Mechanics
Testing
Functional Testing
Test Cases
Conflict Resolution
Problem Solving
Analytical Skill
Microsoft Outlook
Microsoft Excel
Attention To Detail
Supervision
Electrical Engineering
Medical Devices
ISO 9000
Risk Management
Test Management
JIRA
Defect Tracking
Minitab
Statistics
Communication
Scrum
Computer Hardware
Mechanical Engineering

Summary

Job Description:

s a Systems Verification Engineer, you will be responsible for developing and optimizing test cases to implement planned design verification strategies.
You will work closely with the Lead Verification Engineer to develop and validate test methods and support disposables testing, which includes test method instructions, validation protocols, and validation execution.
Your role will involve qualifying electro-mechanical test tools, fixtures, and software necessary to support defined test methods.
This includes installation and operational qualifications (IQ/OQ).

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.
dhere to the Quality Management System (QMS), including the development and maintenance of documentation.

Requirements:

Bachelor's degree in engineering (Mechanical or a related scientific/technical field is preferred).
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.).
bility to work on-site.
Rigorous mindset and attention to detail.
utonomous and able to work with minimal supervision.

dditional Skills & Qualifications:

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).

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 91116760
Position Id: fba248381c34b9f6d087135ac565a7e5
Posted 26 days ago

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