Sr. Manufacturing Engineer

Location:

Santa Rosa, California, United States

Requisition #:

22000DU1

Post Date:

Jul 25, 2022


Position Description:

Design manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling; improve test inspection methods by evaluating technical feasibility, performing reliability studies, and statistical analysis of data; investigate and analyze relevant variables potentially affecting product and processes; develop and improve manufacturing technology by performing feasibility work, process and equipment selection, tooling / fixture and equipment installation and assessment of inputs, outputs and alignment to requirements; coordinate Complaint and Product Failure Investigations, pre- and post- market root cause analysis and Non-Conforming Material Requests (NCMR); provide for the design and manufacture of Class II and Class III medical devices. Navigate various engineering principles within an FDA regulated environment and follow ISO-13485, ISO-14971 and ISO 9001; utilize process validation (IQ/OQ/PQ), DOE and Gage RR. Provide Design for DRM (Design, Reliability, and Manufacturing) practices and tools using Solid works modeling software; utilize Lean manufacturing and Six Sigma methodologies, incorporating GMP (Good Manufacturing Practices), 8D Problem Solving and DMAIC Problem Solving; coordinate various CAPA (Corrective and Preventive Action) planning and implementation; coordinate Risk Deliverables to include Use, Design and Process Failure Mode Effects Analysis (FMEA) and Product Hazard Analysis; conduct studies pertaining to cost control, waste reduction, and inventory control and production record systems. Conduct feasibility studies, determine manpower and cost estimates, and develop engineering criteria. *Multiple positions available.


Basic Qualifications:

Masters degree in Industrial, Mechanical, Electrical, Plastics, Biomedical, or Manufacturing Engineering, Engineering Management, or related field and 2 years of experience in manufacturing or industrial engineering. Must possess a minimum of 2 years experience with each of the following: the design and manufacture of Class II and Class III medical devices; navigating engineering principles within an FDA regulated environment and following ISO-13485, ISO-14971 and ISO 9001; process validation (IQ/OQ/PQ), DOE and Gage RR; Design for DRM (Design, Reliability, and Manufacturing) practices and tools using Solid works modeling software; lean manufacturing and Six Sigma methodologies, incorporating GMP (Good Manufacturing Practices), 8D Problem Solving and DMAIC Problem Solving; CAPA (Corrective and Preventive Action) planning and implementation; Risk Deliverables to include Use, Design and Process Failure Mode Effects Analysis (FMEA) and Product Hazard Analysis; and coordinating studies for cost control, waste reduction, and inventory control and production record systems.
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.