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Senior Manufacturing Engineer
1 month ago
St. Jude Medical Cardiology Division, Inc.
Senior Manufacturing Engineer
Atlanta ,
Georgia
Apply Now
SENIOR MANUFACTURING ENGINEER - St. Jude Medical, an Abbott Laboratories Co. / Atlanta, GA
Responsible for the design, development and transfer of manufacturing processes, fixtures, and equipment for Class 3 Implantable Medical Devices, including production yield and output improvements. Responsible for medical device manufacturing process validation, software validation and equipment/process qualification experience such as Installation Qualification (IQ), Operation Qualification (OQ), and Performance Qualification (PQ). Maintain compliance with U.S. Food and Drug Administration (FDA) CFR Title 21 Part 820 (for medical devices), 21 CFR Part 11, Quality Management Systems, and Environmental Management Systems (EMS) and other applicable regulatory requirements. Responsible for working in and monitoring ISO class 5 and 7 cleanroom environments and handling chemicals (e.g., solvent and acid cleans, wet etching). Automate new and existing processes such as coil winding, frequency testing and tuning, high temperature and pressure equipment. Improve chemical etching and final packaging. Apply statistical analysis using Minitab, Excel, SPC, DOE, and Gage RandR. Responsible for semiconductor manufacturing, MEMS, Medical Device Manufacturing Processes, Process Automation, Cleanroom Environment Monitoring, Test Method Validation and Measurement Equipment/Processes such as Resonant Frequency Testing, Hermeticity Testing, Inductor Coil Manufacturing and Testing, Temperature and Pressure Processing Equipment for medical devices. Support internal and external audits including FDA audit (e.g. site audit readiness, audit responses), risk management, compliance and project management. Evaluate, troubleshoot, and develop production manufacturing processes, equipment, and fixtures, including wafer device handling. Responsible for interfacing with vendors and developing multivariable polynomials for process productivity. Solve supplier-related material issues and initiated and managed engineering change requests. Troubleshoot production equipment such as coil winder and high-pressure conditioning equipment. Write software requirement specifications, perform software testing and validations, and perform 21 CFR Part 11 compliance assessment. Manage equipment and tooling assets throughout lifecycle using software programs such as Windchill (Product Life Cycle Management Software) and Asset Management Software. Work with CAD software such as SOLIDWORKS and AutoCAD. Create characterization reports. Track and used SAP to plan and monitor components and material. Develop and conduct installation, operational, and process qualifications, perform process monitoring, periodic validation review, inspection, and test method validations. Support internal and external medical device-related audits including audit-readiness assessments. Support and lead CAPA (Corrective Actions and Preventative Actions), process and product non-conformances and perform deviation assessments. Verify ISO 13485 compliance and monitor ISO class 5 and 7 cleanroom environment using Vaisala Environmental Monitoring Systems. Document and assess product risks and ensure safety compliance including chemical handling. Write technical and compliance documents, including work instructions, standard operating procedures, material, software, and equipment specifications.
Masters degree or foreign academic equivalent in Mechanical Engineering, Industrial Engineering, Chemical Engineering, Biomedical Engineering, or a closely related engineering field of study (Will accept a Bachelors degree in the aforementioned fields with at least 5 years of related progressive, professional experience in lieu of a Masters degree). Must possess an academic or industrial background in: (i) medical device manufacturing process validation, software validation and equipment/process qualification experience such as Installation Qualification (IQ), Operation Qualification (OQ), and Performance Qualification (PQ); (ii) maintaining compliance with U.S. Food and Drug Administration (FDA) CFR Title 21 Part 820 (for medical devices), 21 CFR Part 11, Quality Management Systems, and Environmental Management Systems (EMS); (iii) working in and monitoring ISO class 5 and 7 cleanroom environments and handling chemicals (e.g., solvent and acid cleans, wet etching); (iv) statistical analysis using Minitab, Excel, SPC, DOE, and Gage RandR; (v) supporting internal and external audits including FDA audit (e.g. site audit readiness, audit responses), risk management, compliance and project management; (vi) software programs such as Windchill (Product Life Cycle Management Software) and Asset Management Software; and (vii) CAD software such as SOLIDWORKS and AutoCAD. Employer will accept any suitable combination of education, training or experience.
An EOE. 40 hrs/wk.Apply on WorkSource Georgia or send Resumes to: Abbott Laboratories, Attn: Elvia Salazar, Willis Tower, 233 S. Wacker Dr., Floor 25, Dept. 32, Chicago, IL, 60606. Refer to ad code: SJM-0018-ES. Abbott Laboratories, Attn: Elvia Salazar, Willis Tower, 233 S. Wacker Dr., Floor 25, Dept. 32, Chicago, IL, 60606. Refer to ad code: SJM-0018-ES.
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