Y.K. Medical Device R&D

• Proven experience leading and managing multidisciplinary groups, budgeting, setting goals, and risk management.
• Vast experience in multidisciplinary projects management.
• Vast experience in system engineering (multidisciplinary projects).
• Extensive experience in development medical devices
• Experienced working with different interfaces: marketing, product management, customers, R & D, regulation, operations and quality.
• In-depth technical understanding, R&D experience, DFM, Design to Cost, EMC and Safety, Lead V&V and System analysis, NPI, Engineering, Manufacturability and Troubleshooting.
• Working knowledge of regulatory standards applicable to design of medical devices, including FDA, ISO 13845, ISO 14971 and IEC 60601 and collateral standards
• Experienced in working under international companies’ methodologies.

• Proven experience leading and managing multidisciplinary group, budgeting, setting goals, risk management.
• Vast experience in multidisciplinary projects management.
• Vast experience in system engineering (multidisciplinary projects).
• Extensive experience in development medical devices
• Experienced working with different interfaces: marketing, product management, customers, R & D, regulation, operations and quality.
• In-depth technical understanding, R&D experience, DFM, Design to Cost, EMC and Safety, Lead V&V and System analysis, NPI, Engineering, Manufacturability and Troubleshooting.
• Working knowledge of regulatory standards applicable to design of medical devices, including FDA, ISO 13845, ISO 14971 and IEC 60601 and collateral standards
• Experienced in working under international companies’ methodologies.

• Proven experience leading and managing multidisciplinary group, budgeting, setting goals, risk management.
• Vast experience in multidisciplinary projects management.
• Vast experience in system engineering (multidisciplinary projects).
• Extensive experience in development medical devices
• Experienced working with different interfaces: marketing, product management, customers, R & D, regulation, operations and quality.
• In-depth technical understanding, R&D experience, DFM, Design to Cost, EMC and Safety, Lead V&V and System analysis, NPI, Engineering, Manufacturability and Troubleshooting.
• Working knowledge of regulatory standards applicable to design of medical devices, including FDA, ISO 13845, ISO 14971 and IEC 60601 and collateral standards
• Experienced in working under international companies’ methodologies.

• Proven experience leading and managing multidisciplinary group, budgeting, setting goals, risk management.
• Vast experience in multidisciplinary projects management.
• Vast experience in system engineering (multidisciplinary projects).
• Extensive experience in development medical devices
• Experienced working with different interfaces: marketing, product management, customers, R & D, regulation, operations and quality.
• In-depth technical understanding, R&D experience, DFM, Design to Cost, EMC and Safety, Lead V&V and System analysis, NPI, Engineering, Manufacturability and Troubleshooting.
• Working knowledge of regulatory standards applicable to design of medical devices, including FDA, ISO 13845, ISO 14971 and IEC 60601 and collateral standards
• Experienced in working under international companies’ methodologies.

• Proven experience leading and managing multidisciplinary group, budgeting, setting goals, risk management.
• Vast experience in multidisciplinary projects management.
• Vast experience in system engineering (multidisciplinary projects).
• Extensive experience in development medical devices
• Experienced working with different interfaces: marketing, product management, customers, R & D, regulation, operations and quality.
• In-depth technical understanding, R&D experience, DFM, Design to Cost, EMC and Safety, Lead V&V and System analysis, NPI, Engineering, Manufacturability and Troubleshooting.
• Working knowledge of regulatory standards applicable to design of medical devices, including FDA, ISO 13845, ISO 14971 and IEC 60601 and collateral standards
• Experienced in working under international companies’ methodologies.