Previous Job
Product Development Engineer
Ref No.: 18-36047
Location: Warsaw, Indiana
Position Type:Full Time/Contract
Start Date: 05/24/2018
Position: Product Development Engineer
Location: Warsaw, IN
Duration: Fulltime(Permanent)

Job Description:
2-4 years experienced profiles having backgrounds in Orhopaedic Product Development would be ideal for us.

Technical/Functional Skills:
This profile will require the candidate identified to work in New Product Development in Medical Devices.
The candidate should be experienced in medical product development – specifically function & design requirements, design verification test, risk analysis, basic regulatory pathways, design History File creation.
The candidate also requires some project management skills.

Experience Required:
Exposure to design & development of medical devices
Exposure to CAD tool (Unigraphics NX is an advantage)
Medical device risk assessment techniques, design failure mode effect analysis (DFMEA)
Experience in medical product development – specifically voice of the customer, function & design requirements, Design Control Plan (DCP)
Exposure to Design History File (DHF) Documentation
Exposure to Verification and Validation
Design verification – Verification test plan, protocol and report preparation
Concept Development
Knowledge in product design and drafting
Understanding of design quality, medical device quality management system
Experience of Project & Program Management concepts, and the associated tools.
Orthopaedic and Spine Product knowledge will be an advantage

Roles & Responsibilities:
Drafting various aspects of DHF
Manage Design Control Plan
Manage Device test plan, write design verification test protocol, test report
Perform basic design engineering – concept design, tolerance stack-up
Perform basic CAD layouts
Perform Design Risk Management and DFMEA
Some level of project management to manage and track overall product development
Interact with all functional groups involved in product development process – Manufacturing, Design Quality, Marketing, External Supplier etc.

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

Bachelor in Bio-Medical Engineering (BS),
Bachelor in Mechanical Engineering (only acceptable if has experience in Medical Device)