As Lab Technician to support Acute Therapies Disposables Lab- the incumbent will have an independent responsibility of following instructions clearly in executing Test procedures, work with R&D engineers to help build Test fixtures/assemblies and assisting with Lab logistics. The candidate will also be a part of Lab Management team to ensures the Laboratory controls are in place in line with applicable international standards and guidelines.
Essential duties and responsibilities:
• Supports the R&D function to execute Lab testing activities relating to Acute Therapies Disposables.
• Support R&D engineers in Test fixture creation, Test set up readiness and test method validation
• Follow instructions and Test protocols with limited guidance from R&D engineers during Test execution.
• Support in Developing and Executing Test Procedures/Functional Requirements testing/Performance testing.
• Develop and Perform Design Verification & IQ/OQ/PQ where applicable.
• Follow QMS, ensure good documentation and Good Manufacturing practices are followed in the Verification Process.
• Support for Instrument Management and Calibration
• Support consumable management/Logistics/ Tracking of parts.
• Support Project execution support for tests involving Reliability equipment’s and Thermal Chambers
• Follow safety guidelines and monitor the same for Lab operations.
• Trouble shoot unfavorable test outcomes and perform RCA.
• Works with external vendors for Transport validation, Stability, Sterilization tests, etc,, for Acute Disposables sets & accessories to define the test scope, author the test plans, test procedures, execute & consolidate the reports
• Collaborate with key stakeholders to resolve tests-related technical issues.
Qualifications & Skills
• Diploma or Bachelor's Degree in Mechanical engineering / Biomedical Engineering / Polymer Engineering Related disciplines of Engineering
• Overall 4 to 8 yrs of experience with minimum 2 years in Medical Device Verification testing [Mechanical].
• Experience in Lab Management and establishing Laboratory controls in line with International Standards regulations [FDA].
• Experience in developing the Procedures and Processes for Engineering labs and Testing facilities. Relevant technical testing/reliability experience in electro-mechanical devices.
• Identify and report any quality or compliance concerns and take immediate corrective / Preventive action as needed
• An understanding of test methods and processes as well as the methods used to verify product in the realms of; mechanical, functional, and environmental testing environments.
• Experience in medical device or similar product development, design verification/validation, system integration (involving software & hardware), risk management, reliability engineering, process validation
• Quality systems Basic understanding of and adherence to FDA, ISO and IEC design control procedures, regulations, and standards.
• Experience in facing internal/External Audits.
• Self-motivated, Good stakeholder management and effective communication skills.
