Research and development manager
3 weeks ago
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 : Auto CAD, SOLIDWORKS, Minitab, Corel DRAW, 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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Thiruvananthapuram, India Terumo Blood and Cell Technologies Full time- 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...
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thiruvananthapuram, India Terumo Blood and Cell Technologies Full timeNew 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...
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