Description : 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.