Second Shift Manufacturing Engineer I - Grand… at Medtronic · Grand…

Summary: Medtronic is a global healthcare technology company dedicated to alleviating pain and restoring health. They are seeking a Manufacturing Engineer II to design and optimize manufacturing processes, focusing on process development, tooling, and automation design to support business needs. Responsibilities: - Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling - Designs arrangement of machines within plant facilities to ensure most efficient and productive layout - Designs sequence of operations and specify procedures for the fabrication of tools and equipment and other functions that affect product performance - Adapts machine or equipment design to factory and production conditions - May incorporate inspection and test requirements into the production plan - Lead or support process validation activities (IQ, OQ, PQ) and documentation - Troubleshoot and resolve manufacturing issues, implementing corrective and preventive actions (CAPA) as needed - Collaborate with R&D, Quality, and Operations teams to support project milestones and timelines - Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality - Develops manufacturing processes that are applicable to statistical process control and may develop those techniques - Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques - Ensures processes and procedures are in compliance with regulations including but not limited to Medtronic policies, FDA regulations, and ISO standards Required Qualifications: - Bachelor's degree with 0 years of relevant experience Preferred Qualifications: - Experience in a manufacturing or process engineering role, preferably in a regulated industry (medical device, pharma, etc.) - Experience with process validation, statistical analysis, and root cause problem-solving - Strong communication and collaboration skills - Experience with Lean Manufacturing and Six Sigma methodologies - Familiarity with FDA and ISO 13485 requirements - Proficiency in AutoCAD and Solid works - Proficiency in ERP systems (SAP is a plus) - Experience in a regulated industry such as medical devices - Strong problem-solving skills and ability to work in a team-oriented environment - Strong project management skills - Work experience with the following: FDA Quality System Regulations, current Good Manufacturing Practices (cGMP), ISO 13485, ISO 9001 standards or equivalent Required Skills: Manufacturing processes design, Process validation, Statistical process control Important Skills: Lean Manufacturing, Six Sigma methodologies, AutoCAD, SolidWorks, ERP systems Nice-to-Have Skills: FDA regulations, ISO standards, communication skills, Collaboration skills, Problem-solving skills, Project management skills Benefits: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, Simple Steps (global well-being program), Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)