Product Development Engineer

$80K - $110K
Posted on 10/18/17 by Bajrang Yadav
Confidential Company
Warsaw, IN
Medical Devices & Diagnostics
$80K - $110K
Posted on 10/18/17 Bajrang Yadav

Technical/Functional Skills

 

This profile will require the candidate identified to act as the single point of contact for the R&D department. The candidate should be experience in medical product development – specifically function & design requirements, design verification test, risk analysis, basic regulatory pathways, design History File creation.

Experience Required

·         Exposure to design & development of medical devices,

·         Medical device risk assessment techniques, design failure mode effect analysis (DFMEA)

·         Experience of Project & Program Management concepts, and the associated tools.

·         Experience in medical product development – specifically voice of the customer, function & design requirements, Design Control Plan (DCP)

·         Exposure to Product Development Documentation

·         Knowledge in Design History File (DHF) creation.

·         Exposure to verification and validation activities

·         Design verification – Verification test protocol and report preparation

·         Concept Development

·         Knowledge in product design and drafting

·         Exposure to CAD tool is an advantage

·         Design Quality experience

·        Orthopaedic and Spine Product knowledge will be an advantage

Roles & Responsibilities

·      Interact with cross functional groups to get gather information on Products

·      Identify gaps in tech files and take measures to remediate

·      Manage Device test plan, write design verification test protocol, test report

·      Perform basic design engineering –tolerance stack-up

·      Perform basic CAD modeling, and layout creation if needed

·      Perform Design Risk Management and DFMEA

·      Some level of project management to manage and track overall product development

Generic Managerial Skills

·      Highly developed negotiation and influencing skills

·     Highly developed and proven written and oral communication skills

·     Organizational / planning skills

·     Strong analytical skills

·      Comfortable with using and facilitating a variety of problem solving methodologies

·      Mentors and develops junior staff within the TCS delivery organization

·     Willing to work with offshore teams in remote locations

Education

Bachelor in Bio-Medical Engineering (BS),

Bachelor in Mechanical Engineering (only acceptable if has experience in Medical Device)

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