Lead Associate - Install Base (IB) Engineer

0 years

0 Lacs

Posted:1 week ago| Platform: Foundit logo

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Work Mode

On-site

Job Type

Full Time

Job Description

Lead Associate, Install Base (IB) Engineer!

Install Base (IB) Engineer is primarily responsible to upkeep of medical device product technical & regulatory compliance files (TRM, PDS, Technical files, Product labels) and be part of product level initiatives. Support team on documentation needed for regulatory and quality standard compliance requirements.

Responsibilities

  • Support Obsolescence, regulatory compliance & certificates related activities. (RoHS, REACH, MDR, CE mark, UL, CSA and NMPA certificates)

  • Support Verification, validation, and root cause analysis activities along with establishing relevant reports and DHF (design history file)

  • Support product level initiatives such as addressing obsolescence, regulatory compliance, VCP, supply chain risk mitigation through design change process and supplier change requests. (ECR/ECO/SCRs).

  • Support install base engineering team for field data analysis and field failure analysis and update in the database tool.

  • Support structuring of Engineering Bill of material and design change activities Via Engineering change control board.

  • Need to work along with Xgen engineering team to support on part development, mechanical/electrical test fixture development, part inspection and testing.

  • Support engineers in the lab to develop and establish experimental set ups, carry out planned experiments and record the test results. Candidate shall have hands on experience in developing test benches for electrical/mechanical sub modules testing, operation of test equipment and recording the test results.

Qualifications we seek in you!

Minimum Qualifications

  • BE/ B Tech in Mechanical/Electrical Engineering with min good years of industry experience.

Preferred Qualifications/ Skills

  • Knowledge in RoHS, REACH, MDR, CE mark process

  • Knowledge in change process and supplier change requests (ECR/ECO/SCRs).


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