Hello,
 
I have this new role with Becton Dickinson
65-70 corp Sbase
No h1s are OPTS- everything else will work.
 
 
Certified Quality Engineer (CQE) and/or Six Sigma Green/ Black Bely
Strong PM Skills
At least 5 years experience product development in Med devices
4 days onsite 1 remote- Salt Lak...

Lead or assist in the development and continuous improvement of quality systems for R&D in compliance with 21 CFR 820, ISO 13485, and EN requirements with a focus on design control. Manage Risk Management plans and reports, promote the use of statistics in quality testing, and apply Six Sigma methodology to support product development.

Hello,
 
I have this new role with Becton Dickinson
65-70 corp Sbase
No h1s are OPTS- everything else will work.
 
 
Certified Quality Engineer (CQE) and/or Six Sigma Green/ Black Bely 
Strong PM Skills 
At least 5 years experience product development in Med devices 
4 days onsite 1 remote- Salt Lake City Utah.
 
<ul type="disc">
<li>Manager must have lead or assists in the development of, and continuous improvement of, quality systems for R&amp;D in compliance with 21 CFR 820, ISO 13485 and EN requirements with specific focus on design control.</li>
<li>Bachelor degree in STEM (Science, Technology, Engineering, Math), and 5 years of engineering experience within the medical device or equivalent regulated industry OR</li>
<li>Masters degree in STEM and one (3) years of engineering experience within the medical device or equivalent regulated industry. 
	The incumbent must demonstrate the potential ability to perform the essential functions of the job as outlined in the duties and responsibilities.</li>
<li>Leads or assists in the development of, and continuous improvement of, quality systems for R&amp;D in compliance with 21 CFR 820, ISO 13485 and EN requirements with specific focus on design control</li>
<li>Leads Risk Management plans/ reports and situational analyses for products under design authorities</li>
<li>Promotes the use of statistics in the testing and control of quality. Applies Six Sigma methodology to support product development process</li>
<li>Contributes to assembly and maintenance the Design History File (DHF</li>
<li>Advanced understanding of design control, disciplined product development processes, regulatory, and quality requirements.</li>
<li>Good working knowledge of medical device regulations and practices (ISO 13485, 21 CFR 820, etc.)</li>
<li>Advanced knowledge of Six Sigma methodology, statistical methods and analysis.</li>
<li>Ability to translate customer needs into design inputs and specifications.</li>
</ul>
 
Minimum Qualifications: 
This position requires: 
- Bachelor degree in STEM (Science, Technology, Engineering, Math), and 5 years of engineering experience within the medical device or equivalent regulated industry OR, 
- Masters degree in STEM and one (3) years of engineering experience within the medical device or equivalent regulated industry. 
The incumbent must demonstrate the potential ability to perform the essential functions of the job as outlined in the duties and responsibilities.

Utah

Advanced understanding of design control, disciplined product development processes, regulatory, and quality requirements

Good working knowledge of medical device regulations and practices (ISO 13485, 21 CFR 820, etc.)

Ability to translate customer needs into design inputs and specifications

Bachelor degree in STEM (Science, Technology, Engineering, Math), and 5 years of engineering experience within the medical device or equivalent regulated industry

Masters degree in STEM and one (3) years of engineering experience within the medical device or equivalent regulated industry

Certified Quality Engineer (CQE)

Six Sigma Green/Black Belt

Project Management

Design Control

Risk Management

Statistical Methods

Medical Device Regulations

Greg / Certified Quality Engineer (CQE) and/or Six Sigma Green/ Black Belt Strong

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Experience in operational management or operational consulting.

Knowledge of Lean (Toyota Production System) methodology.

High school diploma or equivalent is required.

Certificate signifying successful completion of Lean Six Sigma Green Belt certification is required.

Bachelor of Science degree in Industrial Engineering or Industrial Technology is highly desired.

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