Principal Quality Engineer

1 Must have experience or advanced training and demonstrate proficiency(total quality management, statistical methods, problem analysis and resolution, materials science, design of experiments, software development)
2 Completely proficient in relevant products or process development processes.
3 Successful track record of managing wide-ranging activities within the business unit. Demonstrates leadership skills along.
4 Recognized as a technical expert by peers and other personnel within the business unit.
5 Extensive cross-functional team experience, including technical and non-technical work.
6 Ability to organize and present technical and project management overviews without assistance.
7 B.S. degree in Engineering and 8 years of experience, M.S. in
8 Engineering and 5+ years of experience or Ph.D. in Engineering and 3-5 years experience.
9 Demonstrated success in delivering results on several technical challenges.

Experience with:
1 Test specification development or utilizing experimental design / DOE's in the medical device industry.
2 Verification/validation of manufacturing equipment and processes.
3 Interventional products experience- Design control and Design verification; design validation and design history files experience.
4 Experimental design; fundamentals of probability and/or statistical process control.

* Bachelor's degree in engineering or quality and 3 years of experience as a design or quality engineer
* ASQ (or equivalent) Certified Quality Engineer (CQE) or Software Quality Engineer (CSQE)
* 2-4 years direct experience in a Product Development or R&D Organization
* Excellent communication skills
* Self motivating and able to balance multiple priorities and tight deadlines with minimal supervision

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