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.