A BDN client is working on two PMA submissions for a Class III cardiovascular device products and needs an experienced (10 years minimum), well-rounded Quality Engineer (BS in Engineering or related field) with significant medical device experience (specifically working on Class III devices going through a PMA) to work on statistical analysis, design control, and production control related activities. The products are peripheral artery devices (ie grafts, stents, etc.), so having cardiovascular device experience would be a plus. The consultant would work on the following areas: strong statistical analysis – sample size determination and rationales, gage R&R, data analysis, reliability and confidence intervals, process capability, SPC, and Design of Experiments. Class III / PMA experience is needed for this role.