Test Technician - Sys Verification
1d ago
source : Shine

Description : Position Overview

Position Overview

As Lab / Test Technician in Infusion pumps team within Medication delivery business , the incumbent will have an independent responsibility of following instructions clearly in executing Test procedures , assist in maintaining Lab equipment , work with Design engineers to help build Test fixtures / assemblies and assisting with Lab logistics.

Essential Duties and Responsibilities

Execute , perform , summarize , report out verification test activities of components to a full system device : Which includes but not limited to :

User and Functional Requirements testing & Prepare Test Procedures , ,

Support Design Verification ,

Perform Installation / Operational / Performance Qualification Protocols ,

Prepare Traceability Matrices and Final Reports.

Support compliance / closure of Regulatory and Quality requirements before completing Design Outputs / Program Deliverables.

Follow Test instructions and Test protocols.

Follow instructions clearly from Design engineers during Test execution.

Support Design engineers in Test fixture creation , building up & tearing down Test equipment.

Support Lab logistics

Support Calibration activities.

Diagnose , isolate and investigate problem reports.

Works with external test houses (such as EMI , EMC tests for electrical boards and full device) to define the test scope , author the test plans , test procedures , execute & consolidate the reports

Ensure good documentation and Good Manufacturing practices are followed in the Verification Process

Experience in IEC basic safety , EMI - EMC standards

Interacts with design team to resolve tests - related technical issues.

Presents the findings / objective evidences and able to present with rationale with applicability / exclusions

Identify and report any quality or compliance concerns and take immediate corrective / Preventive action as needed. Qualifications / Experience and / or Background

Diploma or Bachelor's Degree in Mechanical engineering , Electrical Engineering , Software Engineering , Computer Science , Bio - Medical , Industrial Engineering or related field

5 to 10 yrs of experience in Verification testing of Software , hardware and System.

Relevant technical testing / reliability experience in electro - mechanical , electrical , or software testing

An understanding of test methods and processes as well as the methods used to verify product in the realms of; software , mechanical , electrical , functional and environmental testing environments.

Understanding of hardware and software product design methodologies and test practices.

Experience in medical device or similar product development , design verification / validation , system integration (involving software & hardware) , risk management , reliability engineering , process validation and Quality systems

Basic understanding of and adherence to FDA , ISO and IEC design control procedures , regulations and standards.

Self - motivated with good interpersonal skills.

Ability to follow instructions clearly.

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