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4.0 - 8.0 years
6 - 16 Lacs
mysuru
Work from Office
Job Description of Biocompatibility/Toxicological Risk Assessment/Chemical Analyst- Senior Engineer or Tech lead 1. Develop and prepare a biological evaluation plan and report. 2. Perform gap assessments of products by reviewing legacy documentation and evaluating device BOMs to determine the applicability of test data to ISO 10993 standard. 3. Write biological risk assessments to ensure all the relevant end points mentioned in ISO 10993 are met. 4. Participate in the analysis of technical issues and in the development of recommendations for project decisions and actions. 5. Good Knowledge in of EU MDR 2017/745, ISO 13485, and ISO 14971. 6. Well Exposure in Chemical and material characteriza...
Posted 3 weeks ago
4.0 - 6.0 years
10 - 12 Lacs
bengaluru
Work from Office
Role & responsibilities Lead end-to-end design and industrialisation of disposable drug reservoirs, infusion sets and fluidpath components for wearable delivery devices. Create concept and detailed CAD, drawings and tolerance stacks optimised for highvolume injection moulding and automated assembly; drive DfM/DfA with suppliers. Prototype rapidly and validate to requirements (leak/occlusion/burst, flow resistance, particulate, usability) with documented V&V. Select materials and joining methods (medicalgrade polymers, adhesives, cannulas, membranes) aligned with ISO 10993, ISO 80369 and ISO 11607; consider sterilisation (EtO/gamma) and package validation. Own DHF artefacts and risk analysis ...
Posted 3 weeks ago
3.0 - 7.0 years
0 Lacs
rajasthan
On-site
As a skilled Mechanical CAD Engineer specializing in enclosure design for wearable electronics, you will play a crucial role in our electronics design company that focuses on developing next-generation wearable products for healthcare and consumer applications. Your main responsibilities will include: - Designing mechanical enclosures for various wearable electronic products such as wristbands, patches, medical wearables, and IoT devices using CAD tools like SolidWorks, Creo, Fusion 360, or equivalent. - Collaborating closely with electronics engineers and industrial designers to ensure the seamless integration of PCBs, batteries, antennas, and sensors. - Developing ergonomic, lightweight, a...
Posted 1 month ago
1.0 - 6.0 years
1 - 6 Lacs
udaipur, rajasthan, india
On-site
Assist in operating and maintaining biomedical equipment. Conduct routine tests and document results under supervision. Gain knowledge in regulatory standards and safety protocols. Support in troubleshooting technical issues and equipment calibrations. Participate in training sessions for professional development.
Posted 1 month ago
2.0 - 7.0 years
2 - 7 Lacs
ahmedabad, gujarat, india
On-site
Equipment Maintenance and Calibration: Perform scheduled preventive maintenance (PM) inspections on medical equipment according to manufacturer specifications and regulatory requirements. Calibrate and adjust equipment settings to ensure accurate and reliable performance, documenting all maintenance activities and findings. Troubleshooting and Repairs: Diagnose and troubleshoot malfunctions, faults, and performance issues in biomedical equipment, utilizing technical manuals, schematics, and diagnostic tools. Repair or replace defective components, parts, or modules to restore equipment functionality and safety. Safety Inspections and Compliance: Conduct safety inspections and electrical safe...
Posted 1 month ago
4.0 - 8.0 years
10 - 15 Lacs
bangalore rural, bengaluru
Work from Office
Job Discretion: JL 5 - Sr Associate role - Electrical or Mechanical Engineering with 5+ years of experience . 3+ relevant years of experience in Design Control of Medical Devices . Life cycle management, making decisions in change management. Change management - Cost reduction, process improvement. Regulatory affairs MDR to EMUDR , follow the regulatory & statutory requirements Work with cross functional teams. Excellent written & verbal communication. Act as project lead – coordinate with different teams - Design Control , MTO, Service, Regulatory Affairs . Team lead experience. Good to have experience in ophthalmology . Consumables and Accessories experience. People with experience in Ster...
Posted 1 month ago
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