Terumo Blood and Cell Technologies | Research And Development Manager | thiruvananthapuram
2 weeks ago
- 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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thiruvananthapuram, India Terumo Blood and Cell Technologies Full timeJOB SUMMARYSenior systems engineer translates the user needs and business needs into the specifications that drive design, implementation, testing of products that are used for collection of blood and blood components. Senior systems engineer will practice design controls in compliance with the quality management systems to deliver on products that are...
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thiruvananthapuram, India Terumo Blood and Cell Technologies Full timeJOB SUMMARYSenior systems engineer translates the user needs and business needs into the specifications that drive design, implementation, testing of products that are used for collection of blood and blood components. Senior systems engineer will practice design controls in compliance with the quality management systems to deliver on products that are...
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thiruvananthapuram, India Terumo Blood and Cell Technologies Full timeJOB SUMMARY Senior systems engineer translates the user needs and business needs into the specifications that drive design, implementation, testing of products that are used for collection of blood and blood components. Senior systems engineer will practice design controls in compliance with the quality management systems to deliver on products that are...
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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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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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thiruvananthapuram, India Terumo Blood and Cell Technologies Full timeJOB SUMMARYAs a configuration management specialist, you will create, plan, implement, and maintain configuration management strategies, policies, tools, and procedures. The responsibilities of the Configuration Management Specialist include:Architect a robust variant and configuration management strategy for complex medical device systems including software...
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thiruvananthapuram, India Terumo Blood and Cell Technologies Full timeJOB SUMMARY Position provides technical expertise in an area of technology as defined. Performs a range of tasks which may include analysis, evaluation, design, coding and testing, installation, maintenance, support, and training under general direction. ESSENTIAL DUTIES Operates somewhat independently in developing strategies for software development and...
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thiruvananthapuram, India Terumo Blood and Cell Technologies Full timeJOB SUMMARYWe are looking for a highly skilled and experienced Senior Embedded Systems Engineer to join our dynamic team. In this role, he/ she will: Be responsible for Designing, developing, and maintaining embedded systems and software for medical devices. Work closely with cross-functional teams to ensure the successful integration of hardware and...
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thiruvananthapuram, India Terumo Blood and Cell Technologies Full timeJOB SUMMARY We are looking for a highly skilled and experienced Senior Embedded Systems Engineer to join our dynamic team. In this role, he/ she will: Be responsible for Designing, developing, and maintaining embedded systems and software for medical devices. Work closely with cross-functional teams to ensure the successful integration of hardware and...
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thiruvananthapuram, India Terumo Blood and Cell Technologies Full timeJOB SUMMARY We are looking for a highly skilled and experienced Mechanical Design Lead to join our dynamic team. In this role, he/ she will: Lead and guide a team of engineers in design and development of mechanical systems related to medical equipment Will be responsible for project planning and execution Will be responsible for the product sustenance...
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thiruvananthapuram, India Terumo Blood and Cell Technologies Full timeJOB SUMMARYWe are looking for a highly skilled and experienced Mechanical Design Lead to join our dynamic team. In this role, he/ she will:Lead and guide a team of engineers in design and development of mechanical systems related to medical equipmentWill be responsible for project planning and executionWill be responsible for the product sustenance...
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