Sagar Tipne
System engineer (Usability Engineer) in Medical Devices testing | Design Control l EU MDR l US FDA
- Role
- Sr System Engineer at Cyient
- Location
- Pune Division, MH, IN
- LinkedIn followers
- 500 followers
About Sagar Tipne
I am a Design Quality Engineer with 8+ years of experience in the medical devices…
Experience
Sr System Engineer
Oct 2024 — Present · Pune, IN
I validate key design inputs such as usability, reliability, performance, supportability, manufacturability, and more. I possess knowledge of design principles for durable, electro-mechanical medical devices.2. Independently, I produce quality engineering documents. I coordinate quality plan design for hardware/software and support stakeholders during quality system, product audits, and inspections.3. I execute assessments of product and system designs, review test data, and analyze market feedback. I perform root cause analysis, solve quality problems, and address deficiencies to embed quality in design.4. I provide oversight of execution of quality, reliability, PMS Plans, Risk Management activities, and all design-related activities, assuring product and process compliance.5. I maintain knowledge of products/services and Quality Engineering techniques. I address diverse problems with sound judgment and frequently interact with supervisors and peers for cooperation.6. As an advisor to subordinates and cross-functional partners, I offer guidance to meet schedules and resolve technical problems effectively. I develop schedules, performance requirements, and may handle budget responsibilities.7. I establish and improve Quality & Regulatory (Q&R) capabilities to support customer service business. I lead in designing and deploying customer service strategies and solutions that exceed customer expectations.
Education
National Institute of Technology Jamshedpur
Master of Technology - MTech, Materials Science
2017 — 2019
BMIT SOLAPUR
Bachelor's degree, Mechanical Engineering
2009 — 2013
Skills
- Catia
- Quality Control
- Cmm Programming
- Autocad
- Ansys
- Quality Assurance
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