Team Member- New Product Development

2 weeks ago


Mumbai, Maharashtra, India Cipla Full time
Job purpose


This role is expected to define the designing, drawing generation, electronics Add on device developing & testing prototype parts 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 Responsibilities

New product design in CAD software like Solid Works, 2 D drawing generation, assembly drawing generation and develop prototypes for testing and method development,
Add on device development

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
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.
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.

Keep a concurrent record on ELN, Cip Dox 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
Maintain technological competency for the department in prototyping (e.g.
3d Printer, casting tools, metal proto machine etc.) and testing facilities including periodic calibration
Sampling and testing of components as per the good laboratory practices.

Requirement

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)

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