Title: Test Engineer with Medical devices experience
Location: Brooklyn Park, MN
Duration: 12 month
Validation Test Engineer with Medical devices experience
Key skills required for the job are:
•Prior medical device manufacturing background and experience required.
• Experience in Test Method Validation and execution, Experience in TMV /Gage R&R and incoming inspections and related procedures.
• Experience in Receiving Inspection. Use of statistical Tools for Analysis such as Minitab etc..
• Process validation working knowledge, writing the test cases of IQ/OQ/PQ protocols and execute the same in production environment.
• Ability to review all the protocols of IQ/OQ/PQ and provide suggestions/solutions.
• Manage the execution of validation protocols and write summary reports, etc., in assurance of timely and cost efficient completion through specialized experience and training as necessary.
• Ability to review Specifications /documents /Drawings , Details Data collection
• Reliability Test plan /protocols creation/ Execution
• Hazard Analysis / Component Design FMEA / review /verification / Updation
• Track the results with CAPA
• Validation documentation against production processes and systems in compliance to internal and external requirements utilizing well developed technical and regulatory skills.
• Process validation and working in a clean room environment and use of inspection, measuring and testing equipment.
• Proven ability of working in a cross-functional team environment. Demonstrated ability to effectively work cross functionally with other departments including Operations, Product Development, QA, etc. as necessary.
• Communicate significant issues or developments identified during production, validation and qualification activities.
• Evaluate validation results of validation protocol executions employing specialized experience and training.
• Ensure validation efforts are conducted in an appropriate and timely manner.
• Ability to make independent decisions and successful track record of influencing key stakeholders.
• Experience in Process FMEA/ Risk management CAPA and RCA and provide inputs to Design team.
• Knowledge on ISO 13485/Part 820 / ISO 14971 will be preferred.
Minimum work experience:3 - 5 Years
Skill and Experience Details:
Minimum Experience Required: 3-5 YEARS Mandatory Skills: Medical Devices Testing Product Testing, Test Automation, Product verification, Application Testing Desirable Skills: Language Skills: English Language
Send resume to email@example.com or firstname.lastname@example.org