SR SYSTEMS ENGINEER: St. Jude Medical, an Abbott Labs Co., in Sylmar, CA seeks qual. Sr. Systems Eng. Responsible for supporting med device product development efforts by performing systems engineering tasks s/a investigating, defining, analyzing, documenting & testing activities to evaluate new design concepts. Masters or foreign equiv in Biomed Eng, Electrical Eng, Software Eng, Comp Sci, or rltd eng fld of study (Will accept Bachelors degree in aforementioned flds w/ min. 5 yrs of rltd eng or R&D development exp in lieu of Masters). Must possess min. 4 years of pro exp in following: (i) supporting med device product development efforts by performing systems engineering tasks s/a investigating, defining, analyzing, documenting & testing activities to evaluate new design concepts; (ii) developing system design input requirements, ensuring tracing between user & business needs & designing input requirements; (iii) Design History Files (DHF), System Verification/Validation Test Strategies, Test Plans, Test Procedures, Test reports & traceability matrix docs for submission to Regulatory agencies (e.g. FDA, TUV, ISO, etc.) while considering Good Manufacturing Practice (GMP)/ Good Documentation Practices (GDP) guidelines & ensuring compliance w/ 21 CFR 820.30 Design Ctrls & ISO 14971 Risk Mgmt; (iv) performing root cause analysis to assist in coordinating non-conformance report (NCR) or Corrective & Preventive Actions (CAPA) rltd activities generated from audits or other observations using tools s/a Jira & ClearQuest; (v) change management tools incl Windchill, Agile, Ensur, or rltd; & (vi) internal & external audits according to federal regulations & industry standards, incl FDA, ISO, TUV or rltd. Employer will accept any suitable combo of education, training or exp. An EOE. 40 hrs/wk. $124,717 - $146,300/year. Send resumes to: Abbott Laboratories, Attn: Elvia Salazar, Willis Tower, 233 South Wacker Dr., Fl. 25, Dept. 32, Chicago, IL 60606. Refer to ad code: SJM-0026-ES.
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