Medical Device Engineer
Kozhnosys · Pune Division, Maharashtra, India
Apply & track with Apply EdgeAt Kozhnosys Pvt Ltd, we are doing groundbreaking innovation that is set to transform cancer diagnosis forever. Our flagship product, CanScan Breathalyser, is designed to make early detection faster, more accessible, and more impactful—bringing hope and change to millions.🚀 Why Join Us? Working in a start-up gives you immense exposure—you’ll touch every aspect of product development, compliance, and innovation.This is a rare opportunity to gain real-world exposure in medical device testing, clinical study coordination, and regulatory documentation. You’ll be part of a team driving innovation with global impact. If you’re planning to grow your career, this is the best spot for you.💡 At Kozhnosys, challenges fuel growth. Only those who love learning new things, pushing boundaries, and challenging themselves thrive here.🌍 Rewarding in Every Way Working here is rewarding not just in terms of growth, but most importantly, in the impact you will bring to the cancer space. We are driven by the motivation to change the world, and here you’ll experience that mission first-hand.Job description
The role involves hands-on medical equipment operation, trouble shooting, servicing, inventory & logistics of consumables and maintenance of the device for the successful trial completion. The person should ensure seamless trial execution, regulatory compliance, and high-quality reporting. The ideal candidate will collaborate closely with principal investigators (PIs), research assistants, and hospital staff to drive research success.The role will involve traveling to different clinical trial sites in Pune and across the country.Key ResponsibilitiesMedical Equipment Handling : Oversee the setup, calibration, maintenance, troubleshooting of CanScan and consumables and accessories in hospital settings.Operation: Assist in monitoring CanScan’s sensor performance, calibration, and patient interaction during trials.Clinical Trial Monitoring: Ensure protocol compliance, data accuracy, and efficient trial execution, identifying and mitigating potential risks.Report Writing & Documentation: Draft detailed trial reports, capturing equipment performance, patient responses, and key clinical insights.Stakeholder Coordination: Engage with PIs, research assistants, and hospital administrators to ensure alignment on trial procedures and findings.Regulatory & Compliance Management: Ensure adherence to GCP standards, hospital ethics approvals, and device-related regulatory frameworks.Overall Trial Management: Maintain documentation, oversee equipment logistics, and support trial teams in day-to-day operations.Qualifications & RequirementsDegree in Biomedical/Electronics/Mechanical Engineering.Familiarity with medical device handling and operation required.Prior involvement in medical equipment validation.Excellent communication and organizational skills to collaborate with medical and research teams.