Ravi Ramrakhyani
Sr. Manager in Medtronic I Product Development I Business Strategies I QMS I Operation Excellence l Stakeholder Management I
- Role
- Sr Manager, Product Development at Medtronic
- Location
- Santa Rosa, CA, US
- LinkedIn followers
- 500 followers
About Ravi Ramrakhyani
Global leader with 15+ years of a successful career in maintaining an effective QMS. Instrumental in designing Business Strategies & Policies for New Product Development & Sustaining engineering. Demonstrate innovations & launch of cutting-edge Design Solutions with strong Leadership Capabilities. Expertise in building High-Performance Org. focused on Regulatory, Compliance & Product Security for Class I, Class II & Class Complex MedTech Devices, IVD & Pharmaceuticals. I HW I SW I Capital Equipment I Software Development Life Cycle IFDA 510k, PMA/PMN, IDE, EUMDR, Japan PMDA, EU-CE, NMPA, BfArM.Compliance Standards: ISO 13485, 21 CFR 820, CFR 210, 211, ISO 9001, AAMI HE75, EN 62366, IEC62304, IEC 60601, EN ISO 14971, ISO 10993, ISO GMP, GLP
Experience
Sr Manager, Product Development
May 2022 — Present · Santa Rosa, CA, US
Sr. Engineering Manager with Medtronic Endoscopy Managing engineering programs (PDP), tracking project goals, objectives, compliance. Portfolio and Stakeholder management. Ensuring programs are resourced and budget and tracking per their objectives. Supporting design decisions and regulatory submission/launch cadence with stakeholder communication.
Education
Symbiosis School of Distance Learning
Post Graduate Degree in Customer Relationship Management, PGDCRM
2007 — 2009
Binghamton University
Masters of System Science and Industrial Engineerin, Industrial Engineering
2007 — 2009
Devi Ahilya Vishwavidyalaya
Bachelor of Engineering (B.E.), Mechanical Engineering
2000 — 2004
Skills
- Product Development
- Dmaic
- Doe
- Cqe
- Iso Standards
- Iso 13485
- Quality Management
- Design Control
- Minitab
- Quality Assurance
- Design for Manufacturing
- Gd
- Quality System
- V&V
- Green Belt
- Class Ii
- Engineering
- Six Sigma
- Spc
- Research and Development (R&D)
- Medical Devices
- Capa
- Quality Control
- Gmp
- Continuous Improvement
- 21 Cfr
- Gage R
- Risk Analysis
- Project Management
- Mdrs
- Fmea
- Ncmr
- Lean Manufacturing
- Fda Gmp
- Validation
- Capas
- Root Cause Analysis
- Fda
- Part 820
- Management
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