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Cincinnati Sub-Zero Products, LLC, is a leading manufacturer of Patient Temperature Management Devices and a Global provider of Industrial Test Chambers proudly serving our customers for over 75 years. We are a wholly owned subsidiary of Gentherm, the global market leader and developer of innovative thermal management technologies. With our employees, we pioneer and shape markets for our customers.

Description

The Engineer II manages and executes product development and manufacturing related projects. 

GENERAL RESPONSIBILITIES:

Assures that product designs are properly implemented by manufacturing personnel

Assures that product design meet UL, CE, and FDA requirements, as well as all international regulatory requirements

Responsible for creating/maintaining product’s design history files

Provides engineering support to assure that ongoing sustaining engineering needs for manufacturing are met

Provides process/tooling design support to ensure high quality, cost effective product manufacturing

Supports Quality Department with analysis of NCM, complaints and CAPAs

Provides engineering support for technical service, customer service, and sales & marketing

Provides engineering support for international device registration

Assures that products designed and manufactured to meet customer requirements

Participates in cross-functional project team activities to assure designs are manufactured in a high quality, cost effective, and timely manner

 


Description

SPECIFIC DUTIES AND RESPONSIBILITIES: (other duties may be assigned as necessary)

  1. Product Line responsibility: responsible for multiple product lines 

Implements product improvement projects 

Resolves customer, production and supplier related issues

Authors test protocols and test reports, as well as execution of the test

Approves test protocols and test reports

Approves product / process documentation

Represents the Engineering Department in Technical /Design reviews

  1. Executes new product / process development projects

REQUIREMENTS:

Must have 5 years of demonstrated experience with sustaining or development of medical devices under 21 CFR 820.

Bachelor’s degree Biomedical Engineering

Able to effectively communicate and present information to general audiences and across departments

 

Cincinnati Sub-Zero Products, LLC, is an Equal Opportunity Employer.  All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, genetic information, sexual orientation, gender identity, disability or protected veteran status.

Job Req ID:  6463


Nearest Major Market: Cincinnati

Job Segment: Medical, Thermal Engineering, Manufacturing Engineer, Engineer, Product Development, Healthcare, Engineering, Research