Carlos Bertolin Volta Email & Phone Number

Baar, Switzerland

As project manager I led a team of 15-20 people to reach a full recertification of an infusion pump, medical device Class IIb. During this project several disciplines were involved, mainly:- Mechanics: mechanical redesign to be compliant with IEC60601-1 and with IEC60529.- Electronics: complete new design of the hardware boards to be compliant with IEC60601-1, IEC60601-2-24 and IEC60601-1-2(EMC series), including functional test design, production test rigs, obsolescence management and cost reduction.- Firmware: complete migration to a new FW platform to be compliant with IEC60601-1 and IEC62304.Many other disciplines were involved. The project basically started from the collection of user needs/stakeholder requirements to the final verification/validation leading to the final certification according to the European regulations. Main activities done during the project execution:- Requirements definition- Detail designs- Development of the different disciplines- Translations and definition of CFD (Customer Facing documents)- Production setup, assembly and manufacturing process.- Usability process over all project phases ending on validation tests with end user- Risk management over all project phases- Issue management during and after development- Test laboratory recertification process for: IEC60601-1, including collateral and particular standards (IEC60601-1-2 4th edition, IEC60601-1-6, IEC60601-1-8, IEC60601-2-24, IEC60529, IEC62133, IEC62304)Project started on 2017-02 and certification was reached on 2017-11.After the recertification I have led several projects to increase functionalities, including a unique therapy setup through encoded barcode technology using Bluetooth technology. This system was designed to improve oncology therapy workflows, increasing the safety and the control of the infusion from prescription to the final infusion to the patient.

Baar, Zug, Schweiz

My responsabilities include:- Hardware development- EMC compliance testing- Create hardware risk mitigation tests- Electronic analysis from customer issues- Obsolescence management Expertise in requirements compliance:IEC60601-1IEC60601-1-8IEC61000-4-xxIEC60601-2-24Sound knowledge in ISO13485

Valencia, Spanien

Responsabilities: Designing and manufacturing of a monoxide carbon sensor.Development of a new measuring method for a monoxide carbon sensor (optical measurement in new chemical reactive material). My main activities were: hardware(mechanic and electronic) and software development of a prototype.

Manchester, Großbritannien

-Visiting Researcher, being the head of the Lab demonstrators for a 2nd year Undergraduate degree.-Production of the Laboratory handout for the module “Data Networking” and afterwards teaching/supervising these labs. Setting the Lab assignments and marking.

Valencia, Spanien

Responsabilities; DSP Software Programming and Electronic Hardware DesignerDuring this time I was involved in the development of the control software of the three/single-phase inverter and communications software system. Design of electronic control board and supervise all phases of the process. Tasks of teaching and supervising scholardship holders in the lab.

Valencia, Spanien

Master Of Engineering (M.Eng.), Industrial Electronics And Control Systems Engineering, 75/100

Activities and Societies: Co-founder of POLIBOT (robotics and electronics association)

Bachelor Of Engineering (B.Eng.), Electrical And Electronics Engineering, 78/100

Activities and Societies: Polibot (Student Robotic Association)

Higher National Diploma, Industrial Electronics Technology/Technician, 80/100