AMIT SHARMA ** Forest Road, West Haven, CT-***** #347-***-****, ac0088@r.postjobfree.com

CAREER SUMMARY A competent professional with over 6 years of experience in Hospital and Medical Healthcare Industry. Proven ability in completing assigned projects on schedule, ensuring compliance without compromising quality, safety and cost. Excellent communication and interpersonal skills with strong analytical, team building, problem solving and organizational abilities. Skilled in maintenance and troubleshooting of biomedical equipment clinically as well as technically. Proficient in IT skills as well.

EDUCATION University of New Haven West Haven, CT Master of Science, (Healthcare Administration) May 2017

Maharishi Dayanand University Bahadurgarh (INDIA) Bachelor of Engineering, (Biomedical) Aug 2009

SKILLS

General: Repairing, Trouble shooting, fault finding, maintenance, calibration and installation of medical equipment. Updating database in the system and experience with design control. PLM knowledge, multi task handling ability with the knowledge of EU Medical Device Regulations in compliance with relevant standards like: ISO13485, 93/42/EEC Life Sciences: US FDA regulations 21 CFR Part 11 (210/211, 150, 56, 58, 311, 314, 820), cGxp (cGMP, cGDP, cGLP) GAMP, IQ, OQ, PQ, RTM, SOP, Summary Reports, Audit trials Testing and Tracking tools: Test Director, Quick Test Professional, Load Runner, Quality Center. Databases: MS SQL, MS Access, Oracle Project Management: MS Office Suite (Microsoft Word, PowerPoint, Excel)

PROFESSIONAL WORK EXPERIENCE

Cygnus Medicare Pvt. Ltd New Delhi (INDIA),

(Manager Biomedical) Sep 2014-May 2015

Attended safety committee meetings and Oversee department development

Provided Clinical in-service training for new and old equipment to all newly hired staff.

Assists in research of methods and technologies to support clinicians and patients with tools to evaluate function both pre- and post-operatively.

Researches, explores, and develops new intellectual property based on clinical needs.

Understands clinical issues, defines design parameters, and ensures that the final product meets the customer’s needs.

Develops prototypes for new products based on clinical input and feedback.

Works with outside vendors and consultants as needed.

Contributes to the development of risk management files, design history files, and document deliverables to ensure compliance with international regulatory agency design control regulations.

Follows rigorous design control methodology and write concise requirements specifications, architecture specifications, and design description, verification plans, and test cases.

Executes specified requirements definition, risk analysis, verification, validation, and design transfer processes for all products developed

Provides technical support including design rationale, surgical technique, specification guides, and presentations for marketing and sales.

Understands clinical issues, define design parameters, and ensure that the final product meets the customer’s needs.

Interfaces with other functional departments including quality assurance, regulatory affairs, and marketing, to ensure effective collaboration and teamwork.

Involved in procurement of new biomedical equipment after dealing with different MNC’s vendors.

Visited every hospital site on weekly basis to review biomedical current issues and breakdowns and provided technical recommendations for the same.

Handled and commanded a team of junior biomedical engineers at every site involved in the servicing, maintenance and troubleshooting of all medical equipment present at the site.

Max Super Specialty Hospital New Delhi (INDIA) (Senior Biomedical Engineer) Sep 2012-Sep 2014

Used to manage installation, preventive maintenance and all the biomedical related issues of the hospital

Maintained medical breakdown, installation, and preventive maintenance and calibration record in files as well as system’s software for NABH processing.

Repair, install, maintain, calibrate and inspect medical equipment and instrumentation to ensure compliance with established industry standards, CSA standards, and manufacturer's operational specifications.

Performs preventive maintenance, incoming equipment inspection and routine electrical safety inspections or other procedures as required

Routinely communicates equipment issues and supply needs to the Charge Technologist.

Provides technical assistance and instruction to users and team members regarding equipment operation and maintenance.

Assists in maintaining adequate inventory of equipment and supplies.

Maintains accurate records of equipment including maintenance history, associated costs and duration of work.

Modification of existing equipment for custom applications or updated function, fabrication of custom equipment.

Adheres to worker responsibilities as set out in the Occupational Health & Safety Act, hospital safety policies, and dept/unit established procedures.

Faber Star Facility Management (FORTIS HOSPITAL) Noida (INDIA) (Biomedical Engineer) Sep 2010-Sep 2012

Attend and respond to user service requests in a timely manner

Provided organized and planned solutions for all biomedical problems

Handled incident investigation/Risk management

Maintain files for various documentation work associated with medical equipment installation, preventive maintenance, servicing, calibration certificates, equipment purchasing and making work orders for the same.

Assisting outside engineers or service providers for hours with tools and other facilities while repairing big machines like X-Ray, MRI, CT Scan, PET Scanner, Cath Lab etc.

Attending breakdown calls and fault finding at primary level and providing a solution to maintain the working atmosphere keep going.

DONE INTERNSHIP WITH GXP VALIDATION SERVICES, LLC, IN FOLLOWING

(12th Sep 2016 to 12th Dec 2016)

Strong understanding of pharmaceutical/medical device regulations like FDA 21 CFR part 11, 21 CFR part 210, 21 CFR part 211.

Hands-on experience with GAMP 5 Guideline, Software Development Life Cycle (SDLC) methodologies, documenting project and validation deliverables, gathering business, functional and system requirements, developing testing and validation protocols (IQ/OQ/PQ), summarizing reports and final validation packages.

Experience in developing User Requirement Specification(URS), and Functional Requirement Specifications(FRS).

Writing technical documentation, User Guides, Online Documentation, Report Generation and Software Documentation.

Experience in reviewing and approving the Validation Documents including SOPs, IQs, OQs and PQs.

Excellent documentation skills in compliance with Good Documentation Practices (GDP).

Maintained and updated traceability matrix.

Pre-Approval and Post Approval of Test Scripts and completing the Qualification Reports.

Experience in writing and executing user acceptance testing(UAT).

Experience in change control procedures for software applications.

Excellent organizational, interpersonal, written and oral communication skills.

Proficient in working individually and as a part of a team.

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