Asst. Manager- New Product Development (R&D)

Asst. Manager- New Product Development (R&D)

Job Description:

• New products development and support sustenance activities for all TBCT products using design control process following ISO 13485 standard.
• Significant experience in functional and simulated use tests of medical devices, test methods development and Validation.
• Knowledge on Design Control processes, Design verification activities with protocol and report preparation is a must. Exposure to manufacturing processes is an added advantage.
• Knowledge on maintenance of lab equipment, calibration is required.
• Support in materials development including packaging and RM changes as per regulatory requirement and market needs.
• Support Marketing and Sales team with technical inputs in tender related activities and product brochure releases.
• Manage a team of 4 to 6 people and possess experience in project management.
• Ability to complete projects on-time and collaborate and support cross functional teams across production sites and global R&D sites
• Good Understanding & knowledge of various standards such as ISO 13485, ISO 14971, ISO 3826, ISO 10993, ISO 15223 etc. Exposure to EUMDR and other Regulatory requirements required.
• Ability to perform Gap assessment for standards and prepare equivalency reports. Experience in facing regulatory body audits on design control process is required
• Perform root cause analysis for failures. Knowledge in analysis using QC tools is essential.
• Perform statistical analysis of data for investigating trends, patterns, and relationships using quantitative data
• Create and update standard operating procedures (SOP) employed in new product development
• Support prototype, sample and design verification builds and coordinate activities with other departments including production, planning, procurement, stores, logistics etc.
• Experience in using product life cycle management software.

Software: AutoCAD, SOLIDWORKS, Minitab, CorelDRAW, MS office, Excel

Qualification: Bachelor’s or Master’s degree in Engineering or Science

Experience: 7-10 years in Medical device industry, preferably involved in design and development

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