The Senior Lean Manufacturing Engineer is responsible for leading complex Lean and Six Sigma initiatives across manufacturing while supporting the transfer of new and modified products and processes from R&D into Operations. This role serves as a senior technical and continuous improvement resource, driving measurable improvements in safety, quality, delivery, cost, labor efficiency, throughput, capacity, and manufacturing flow. The position leads cross-functional improvement and design-transfer projects, mentors engineers and operational teams in Lean problem solving, and ensures assigned product transfers are manufacturable, scalable, validated, documented, and successfully transitioned into production.

Essential Duties and Responsibilities:
• Leads and coordinates assigned R&D-to-manufacturing transfer activities with R&D Engineering, Quality, Regulatory, Operations, and Manufacturing Engineering for new and modified products and processes;
• Estimates production cost, determines time standards and makes recommendations for tooling and process requirements of new or existing product lines;
• Train manufacturing/quality control personnel on processes, equipment and acceptance criteria;
• Develop and write test protocols, test reports, technical documents, etc. to support manufacturing needs;
• Lead complex, high-impact process improvement initiatives aligned with business and operational priorities.
• Develop floor layout or assist with production equipment setup of new or existing production lines/equipment;
• Lead site-level Lean and Six Sigma initiatives based on the strategic priorities and needs of the company;
• Lead A3 and DMAIC problem solving to create stability, improve process capability, and eliminate recurring manufacturing issues across the organization;
• Manage project feasibility and business case development, matching projects to the strategic priorities of the organization;
• Drive local leadership and executive-level leadership to actions to improve operations performance;
• Apply principles of Lean, such as Takt Time planning, Kaizen, Single Piece Flow, Pull, Standardized Work, Value Stream Mapping, Visual Factory Management, Continuous Improvement, and Standard Factory;
• Lead implementation of Lean transformations and serve as a senior subject matter expert and coach during implementation;
• Provide support to functional leaders with planning and implementing Lean projects that tie strongly to business financials;
• Lead complex cross-functional projects that cut across organizational and functional boundaries, from project definition through implementation and sustainment;
• Conduct Kaizen events using Lean tools to achieve desired results with measurable metrics while mentoring and coaching others to drive project execution and implementation.

Supervisory Responsibilities:

None

Education, Qualifications and Skills:
• A Bachelor's Degree in Industrial, Manufacturing, Mechanical, Electrical Engineering, or a related engineering discipline; Industrial Engineering preferred;
• Manufacturing Engineering experience in Medical Devices, specifically Cardio-Vascular products is preferred;
• 7+ years of progressive manufacturing, industrial engineering, Lean, or continuous improvement experience, including 5+ years of Lean deployment;
• 5+ years of project leadership experience leading cross-functional projects from initiation through commercialization or implementation within the medical device or a similar regulated industry;
• Six Sigma Green Belt required; Black Belt preferred. Demonstrated application of DMAIC, root-cause analysis, statistical methods, and process capability;
• Experience in CTQs assessment and translating CTQ into manufacturing specifications;
• Experience in creating and revising operating procedures in a document control system;
• Experience in performing gap assessments between design outputs and manufacturing specifications;
• Advanced working knowledge of Value Stream Mapping, Kaizen, A3, 5S, Standard Work, Visual Management, Takt Time, line balancing, flow, pull systems, and waste reduction to improve quality, labor efficiency, throughput, and capacity;
• Demonstrated record of leading manufacturing process improvements with measurable improvements in quality, productivity, labor efficiency, cycle time, throughput, capacity, or cost;
• Experience with Minitab or equivalent statistical software for process capability, statistical analysis, DOE, and continuous improvement preferred;
• LabVIEW experience is a plus;
• Strong hands-on prototyping skills;
• Ability to coordinate test sample builds;
• Strong oral and written communication skills;
• Strong interpersonal and leadership skills, including the ability to mentor engineers and coach cross-functional teams in Lean and structured problem-solving methods;
• Ability to work independently and within a cross-functional team;
• Strong problem-solving skills;
• Proven project management skills with the ability to independently lead multiple high-impact initiatives and communicate effectively with site leadership.