Sr. Manufacturing Engineer

Role Title: Senior Manufacturing EngineerWork Location: Eagan, MN (Fully On-site)Duration: Direct HireOverview:Our client is seeking a full-time Senior Manufacturing Engineer to join their team on-site in Eagan, MN. The ideal candidate will have extensive experience in the medical device industry, particularly in R&D and automation. This role involves overseeing manufacturing processes, implementing engineering techniques, and optimizing machining operations.Responsibilities:Process Design and Optimization: Lead the design, development, and optimization of manufacturing processes to enhance efficiency, quality, and cost-effectiveness.Equipment and Tooling: Oversee the selection, installation, and validation of manufacturing equipment and tooling, ensuring efficient operation and maintenance.Process Validation: Develop and implement comprehensive process validation protocols (IQ/OQ/PQ) to meet regulatory and quality standards.Data Analysis: Analyze production data to identify trends, root causes of issues, and opportunities for improvement. Implement corrective actions as needed.Continuous Improvement: Lead initiatives using Lean, Six Sigma, and other methodologies to enhance processes and reduce waste.Collaboration: Work closely with cross-functional teams, including R&D, quality assurance, and production, to resolve technical issues and support new product introductions.Documentation: Maintain detailed documentation of manufacturing processes, including process flow diagrams, work instructions, and validation reports.Training and Mentorship: Provide technical guidance, training, and mentorship to junior engineers and production staff.Compliance: Ensure all manufacturing processes comply with relevant safety, quality, and regulatory standards, including FDA and ISO requirements.Project Management: Manage multiple projects simultaneously, ensuring timely completion within budget and quality standards.Qualifications:Bachelor's degree in Manufacturing Engineering, Mechanical Engineering, Biomedical Engineering, or a related field (Master's degree preferred)Proficiency in CAD software, statistical analysis, and process optimizationStrong analytical and problem-solving skillsExcellent communication and teamwork abilitiesProven project management skillsHigh attention to detailDemonstrated leadership skills and the ability to mentor and train junior engineersAbility to work independently and manage multiple projects in a fast-paced environmentExperience in the medical device industryR&D and automation experienceAt least 5 years of relevant experiencePositive attitude, high energy, and a willingness to take on more responsibilitiesNice-to-Haves:Leadership/mentorship experience, with potential to oversee a technician and internLean Six Sigma Black Belt certification or equivalent