Sr. Manufacturing Engineer

Position Description:

Sr. Manufacturing Engineer for Medtronic, Inc located in Fridley, MN.  Coordinate manufacturing engineering project plans by utilizing project mgmt. skillsets that include creating timelines, tracking budgets and understanding resource allocations; coordinate Investigations and Non-Conforming Material Requests (NCMR); coordinate various CAPA (Corrective and Preventive Action) planning and implementation; 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) and Gage R&R.  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), Root Cause Analysis tools including 6M and 5-Whys, and DMAIC (Define, Measure, Analyze, Improve and Control) Problem Solving; coordinate Risk Deliverables to include 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 using Agile MAP.  Conduct feasibility studies, determine manpower and cost estimates, and develop engineering criteria.   * Position works a hybrid model and will be onsite in Fridley, MN location – 4 days per week.  #LI-DNI.

Basic Qualifications:

Master’s degree in Industrial, Mechanical, Biomedical or related engineering field and 2 years of experience as a manufacturing or industrial engineer.  Or alternatively, Bachelors’ degree in Industrial, Mechanical, Biomedical or related engineering field and 5 years of experience as a manufacturing or industrial engineer. Must possess at least two (2) years’ experience with each of the following: Design and manufacture of Class II and Class III medical devices; Working w/in FDA regulated environment, ISO-13485, ISO-14971, and ISO 9001; IQ/OQ/PQ and Gage R&R; DRM using Solid works modeling software; Lean manufacturing and Six Sigma methodologies, GMP, 6M, 5-Whys, and DMAIC; DFMEA, PFMEA, and Product Hazard Analysis; Coordinating studies for cost control, waste reduction, and inventory control and production record systems using Agile MAP.

Salary:  $121,400 to $146,400 per year