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Senior R&D Engineer/ Project Lead
Ref No.: 18-50221
Location: Salt lake city, Utah
Position Type:Full Time/Contract
Start Date: 07/17/2018
 
TCS Profile Tata Consultancy Services (TCS) is a global leader in IT services, digital and business solutions that partners with its clients to simplify, strengthen and transform their businesses. We ensure the highest levels of certainty and satisfaction through a deep-set commitment to our clients, comprehensive industry expertise and a global network of innovation and delivery centers. TCS has been recognized by Brand Finance as one of the Big 4 Global IT Services Brands. Our continued industry-leading growth is a testament to the certainty our clients experience every day. TCS offers a consulting-led, integrated portfolio of IT, BPO, infrastructure, engineering and assurance services. This is delivered through its unique Global Network Delivery Model™, recognized as the benchmark of excellence in software development. A part of the Tata Group, India's largest industrial conglomerate, TCS has over 324,000 of the world's best trained consultants in 46 countries. The Company generated consolidated revenues of US $ 15.15 billion for year ended 31 March, 2015 and is listed on the National Stock Exchange and Bombay Stock Exchange in India. For more information, visit us at www.tcs.com. TCS delivers a level of certainty that no other firm can match—to our clients and to our employees. Come join us and experience certainty in your career.
RGS ID 2418881
RGS ID creation date
(dd-mmm-yy)
7-JUL-18
# of requirements 1
Job Title Senior R&D Engineer/ Project Lead
Relevant Experience
(in Yrs)
8-10 years
Technical/Functional Skills
Must have skills*
Excellent Knowledge of Medical Device Design Control Requirements. Lead Product Development and DHF Remediation Project. Update Design History File and Risk Management File. Write Test Protocols and Test Results. Oversee and troubleshoot during design verification testing. Good knowledge and understanding of ISO-13485 requirements
 
Good to have skills*
Experience working with Venous Catheters, Ports desired. Minimum of 5 years of experience within the medical device industry with a Bachelor's degree or advanced degree (Master's or PhD) plus 3 years of engineering experience within the medical device or equivalent industry.
Experience Required 8+ years with at least 5 years in Medical Device Industry
Roles & Responsibilities Identify all applicable documentation, Identify missing documentation, Baseline product Testing, Creating an assessment of DHF gaps – All gaps are defined, DIR and RM updates to support phase two testing, Define extent of MDR/Complaint reduction activities that will happen in parallel Establish the detailed project plan, Determine if and what MDR/Complaint reduction activities will be pursued with remediation, Remediate the gaps Protocols (leverage "predicate” protocols to speed up writing)conditioning, Testing, Reports Process Validation and Component Qualification work, Deliverables updates to reflect remediation activities, Launch of any MDR/Complaint reduction changes
Generic Managerial Skills The Senior R&D Engineer ensures project is as per schedule and provides guidance to team members.
Education B.S. or B.A. degree required.  MS preferred
Start date (dd-mmm-yy) 1-Aug-18
Duration of assignment (in Months) Long Term
Work Location (State, City and Zip) Salt Lake City, UT
Client Billing Rate $/hr  
Rates payable to vendor $/hr  
Key words to search in resume Medical Device, Sr R&D Engineer, Design Controls, Risk Management
Prescreening Questionnaire The job profile requires working with cross functional team to ensure compliance to FDA and other applicable regulations.   In this role, Consultant will mainly sustaining existing product lines by supporting review and implementation of Change Control Plans and ensuring compliance to regulations of various agencies.  Supports applicable regulations including ISO, local, state, and/or federal requirements. Responsible for understanding product registration and re-registration requirements in various countries and working with local regulatory teams to support product lines