This role is expected to define the testing and validation scheme for medical devices at various stages of the development, implement such testing, verification of device performance and validation of robustness and safety of the developed devices, and document the relevant output to support filing and approval of these developed devices
Key Accountabilities (1/6)
Define product safety, quality, and compliance checklist for shortlisted projects
Define a detailed checklist as per relevant SOPs, experience of other product files, and product specific guidance to evaluate safety, quality, and compliance of the shortlisted projects
Detail the testing methodologies, standards, requirement of certifications and other department collaboration requirements basis the checklist
Key Accountabilities (2/6)
Make a verification and validation (V&V) plan and write suitable protocols
Make a V&V plan by tasks, timelines, costing, external agencies vs inhouse facility
Write, get reviewed and approved suitable verification protocols with ROC, QC, RA functions e.g. robustness, stability, safety and ISO compliances
Key Accountabilities (3/6)
Develop testing methods, jigs, and processes to implement the V&V plan and protocols
Build testing jigs, setup, and measurement scheme to conduct validation studies and noting any anomalies or risks in the product at various stages of development
Develop external labs, vendors, testing facilities required to carry out validation studies at prototype, scaled up or near commercial stage of product development.
Key Accountabilities (4/6)
Document, report the results of V&V and troubleshoot risks and issues the product
Keep a concurrent record on ELN, CipDox or suitable record book in a compliant manner of the testing completed with observations if any
Discuss with design team the risks, issues and areas of improvement identified in the product design/performance/features or parts to ensure that these risks are mitigated before the next iteration testing
Key Accountabilities (5/6)
Maintain technological competency in prototyping and testing facilities including periodic calibration Maintain technological competency for the department in prototyping (e.g. 3d Printer, casting tools, metal proto machine etc.) and testing facilities including periodic calibration
Key Interactions (1/2)
Cipla Devices team – device design understanding, critical quality attributes, tech transfer attributes
Finance team- approval for testing budget, POs and exceptional capex items (weekly)
Regulatory – testing and validation protocols, USP 661 etc. to be maintained (Weekly)
QA/QC- relevant certification and documentation for medical devices under scale up ( Fortnightly)
Key Interactions (2/2)
Mould manufacturers – scope, timeline and mould development management, FOT (Regular basis)
V&V agencies, testing laboratories
Education Qualification
Bachelor’s degree in mechanical, electronics, mechatronics, or industrial engineering
Knowledge of statistical methods and analysis is a must
Relevant Work Experience
3+ years’ experience in design, validation, and testing of medical devices, drug-device combination at reputed pharmaceutical or medical device company
Disciplined and well-organized in validation documentation (plans, requirements, drawings, design reviews, and test methods)
Experience working with ISO requirements and other relevant guidelines and regulations (PPAP)
Experience in medical device manufacturing (direct operations/team handling) highly welcome
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