This CV summarizes the personal and professional details of Sayan Biswas. It includes his educational qualifications including degrees in ICSE, ISC, and B.E. in Medical Instrumentation. It outlines his work experience as a Project Engineer at Larsen & Toubro Ltd. and Skanray Technologies Pvt. Ltd. It provides a detailed job description of his responsibilities in areas like product development, documentation, quality assurance, and project management for various medical devices.

1. CURRICULAM VITAE
PERSONAL DETAIL:
Name:Sayan Biswas
E-mail id:biswassayan7474@gmail.com
Contact no : 9742876711
EDUCATIONAL QUALIFICATION:
DEGREE LEVEL YEAR SCORE
1. ICSE 2005 83.6 %
2. ISC 2007 85.6%
3. B.E.( Medical Instrumentation) 2011 9.00 (CGPA)
WORK EXPERIENCE:
COMPANY1: Larsen & Toubro Ltd. – Medical Device &Equipment Division
Joining Date: 1st July 2011
End date:17th January 2013
Location: Mysore
Job Role: Project Engineer
COMPANY 2: Skanray Technologies Pvt. Ltd. – Healthcare Divisions
Joining Date: 18th January 2013
End date: Till Date
Location: Mysore
Job Role: Project Engineer

2. JOB DESCRIPTION:
 Development of Product. Project co-ordination between User Interface developers and Data
Acquisition System developers, hardware teams and other cross functional teams as required for
the development of the product.
 Understanding of the Application.
 Change Management activities.
 Cross Functional Team Activities
 Coordination with the Quality Team for product testing, verification & validation.
 Understanding of the bugs reported and getting it resolved.
 Review of QA reports.
 To keep track of the problems faced in Production and to resolve it.
 To interact with the Cross Functional Team from planning of the Pilot lot till the roll out of the
1st Production lot.
 Field trials for the testing units.
 Documentation
 To prepare, maintain & update the various documents for the product.
For e.g.: Bill of Material, Risk Management File, and Design Requirement Specification &
Software Requirement Specifications of the product.
 To prepare and provide the required documents for FDA & CE certification.
 To provide inputs for the documentation of Operating Manual & Service Manual to the
respective teams.

3.  Post Design Release
 To conduct training sessions for the service & marketing engineers to explain the product and
its application.
 To conduct field trials, interact with doctors and end users and to get their feedback.
 To discuss the feedback with the team and to implement the same, where feasible.
 To attend to the field reported problems and co-ordinate with the hardware/software teams
where required.
 Interaction with the Marketing team, planning for the product trials and demo.
 Review of the sales brochures and pamphlets.
 Standards
 Understanding of ISO14971 standard.
 Acquainted with ISO13485 standard.
 Adequate knowledge of IEC62304 standard.
 Overview of the AAMI standard.
 Testing for 60601-2-25
 Projects
 Multi parameter Patient Monitoring System
 ECG machine

4.  Cardiac Stress Test Setup ( Cardiac Treadmill )
 Other Projects
 To understand the implementation & application of the Cardiac Output (CO) module.
 To give demo and conduct field trials of the module.
 To train the Marketing & Service team about CO.
 To compare and select an alternative display for a product.
 Software skills
 MS Office
 C , C ++
 Training Received
 Quality System Regulation 21 CFR 820