Sr. Product Engineer
July 2015 to September 2017
Anesthesia Safety Products
August 2014 to June 2015
Beth Israel Deaconess Medical Center
Clinical Research Coordinator at the Hematological Malignancies & Bone Marrow Transplant Center
June 2011 to July 2013
November 2007 to June 2011
What company does David Qiu work for?
David Qiu works for EndoEvolution, LLC
What is David Qiu's role at EndoEvolution, LLC?
David Qiu is Sr. Product Engineer
What industry does David Qiu work in?
David Qiu works in the Medical Devices industry.
Sr. Product Engineer @ EndoEvolution, LLC From July 2015 to September 2017 (2 years 3 months) Raynham, MAMechanical Engineer @ Anesthesia Safety Products • Managed design project for cost reduction on a Medical Device disposable product with respect to Design Control regulations • Created design drawings for the internal printed circuit board for the electronics package of an automated medical device. • Devised an Inventory Control system and instituted Lot Control for manufacturing parts through the creation of a database and revision of the Document Control system.• Coordinated project management efforts with R&D to complete four new Medical Device prototypes • Verification and Validation activities: developed test plans for IQ/OQ of production tools, and created V&V reports for a test fixture used in production.• Worked closely with contract manufacturers to insure GMP controls in production of Medical Device and disposable products.• Supported the Quality Team in preparation for an FDA Quality System Inspection in 2014. • Developed several bill of materials, device history records, and assembly instruction documents for production use. From August 2014 to June 2015 (11 months) Woburn, MAClinical Research Coordinator at the Hematological Malignancies & Bone Marrow Transplant Center @ Beth Israel Deaconess Medical Center • Managed clinical trials, FDA regulatory updates, initiating variable phase clinical trials with trial sponsors, handle hospital Internal Review Board audits and sponsor audits visits• Restructured the Bone Marrow Transplant program. Included assisting in the initiation of ‘home-grown’ clinical trials, collaborating with Dana Farber Cancer Center groups in joint clinical trials, consolidating and diversifying clinical trials offered in the hospital• Worked closely with patients at each clinic visit: ordered blood chemistries, collected and processed blood/saliva samples, questionnaires, and data collection charts From June 2011 to July 2013 (2 years 2 months) Boston, MAManufacturing Engineer @ Arteriocyte • Lead engineer and Project manager for three new medical device disposable kits, from concept to release, prepared and designed 3D solid modeling of medical device components• Design Control, including Validation and Verification test activities; operated in compliance with Design Control• Managed a production team, which consisted of: selecting, interviewing, and training of employees, creating daily job schedules, authoring work instructions, bill of materials, and device history records• Worked closely with Quality team to achieve ISO 13485 BSI CE certification, passed FDA inspections, CAPAs, NCMRs, complaints, and other GMP compliance areas• Made key decisions on manufacturing, equipment, and warehouse facility setups; implemented Lean six sigma to the manufacturing process From November 2007 to June 2011 (3 years 8 months) Hopkinton, MA
Introversion (I), Sensing (S), Thinking (T), Perceiving (P)
2 year(s), 3 month(s)
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