DEVELOPMENT QUALITY ENGINEER II St. Jude Medical, an Abbott Labs Co. / Plymouth, MN Participate in or lead teams in supporting quality disciplines, decisions, and practices such as representing the Design Quality function as a Core Team Member. Manage on-time completion of Design Control Deliverables. Create and ensure on-time execution of Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects. Accountable for Design Verification and Validation planning and execution, including active cross-functional root-cause analysis determination and resolution activities for design verification . Lead or support Risk Management activities, including analyzing field data to support new product development, supporting Failure Mode Effects Analysis, generation of risk management plans/reports, and completion of hazard analysis. Draft Quality Plans, Design Verification & Validation, Trace Matrix, Design Review, and Requirements trace documentation . Support design test and inspection method development, and lead test method validation activities. Ensure Device History File (DHF) content completion, integrity, and regulatory & standards compliance by collaboratively identifying, communicating, and resolving gaps. Support manufacturing process development and qualification for new product commercialization and product changes. Support internal and external audit responses and on-time product re-certifications. Support and ensure the establishment of objective, measurable, discrete, and verifiable customer, and product requirements. Support and ensure objective component specification definitions. Support the development and review of biocompatibility and sterilization validations. Support R&D product builds for bench testing, animal lab, and first in human activities. Support US and international regulatory team such as EU, China, Asia pacific etc. with product submission, associated deficiencies, and get product approval. Complete Document Change Request Reviews in a timely and objective manner. Participate in Corrective Action/Preventive Action (CAPA) process including the investigation of failures or deviations. Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. Employ experience with Medical Device Design Assurance, CAPA, risk management, ISO 13485, FDA 21 CFR 820, EUMDR, NMPA and FDA medical device regulations and ensure compliance with the same. Bachelor s degree or foreign equivalent in Engineering or a related field of study with at least 2 years of professional engineering experience in: (i) managing on-time completion of Design Control Deliverables; (ii) Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects; (iii) root-cause analysis determination and resolution activities for design verification; (iv) Medical Device Design Assurance, CAPA, risk management, ISO 13485, FDA 21 CFR 820, EUMDR, NMPA and FDA medical device regulations; and (v) drafting Quality Plans, Design Verification & Validation, Trace Matrix, Design Review, and Requirements trace documentation. An EOE. 40 Hrs./wk. $74,506 - $114,700/year. Send resumes to: Abbott Laboratories, Elvia Salazar, Willis Tower, 233 S. Wacker Drive, Floor 25, Dept. 32, Chicago, IL 60606. Refer to ad code: SJM-0029-ES