Lean Leader

Harland Medical Systems; Eden Prairie (MN); On-site; USD 100,000 - 140,000; Full time

Job summary

Harland Medical Systems is seeking a Senior Lean Improvement Leader to drive continuous improvement across products, operations, and processes. The role partners with the Senior Management Team to implement a company-wide lean strategy aligned with customer needs.

The candidate will lead a Lean transformation roadmap, guide 5S rollout, and facilitate Kaizen events to eliminate waste and improve efficiency. A strong background in medical device regulation and Six Sigma is preferred.

Qualifications

• Bachelor’s degree in Engineering, Business Management, Operations, or similar.
• 5+ years in a lean change agent role within a company.
• Experience with lean in a medical device and regulated environment, SOPs in FDA-regulated setting.
• Strong leadership to drive organizational change and engage teams.
• Proficiency with 5S, Value Stream Mapping, Kanban, Six Sigma.
• Hands-on project and change management with measurable results.
• Strong analytical skills to interpret data and identify improvements.
• Excellent communication and leadership abilities.
• Results-driven with culture of continuous improvement.
• Familiarity with manufacturing, logistics, or service workflows

Responsibilities

• Support development of a strategic roadmap for lean transformation.
• Improve workplace organization and operational efficiency, including 5S.
• Align lean initiatives with business objectives and customer needs.
• Lead Kaizen events to promote small, incremental changes.
• Stay updated on industry trends and best practices in lean management.
• Identify bottlenecks and apply root-cause analysis to fix issues quickly (PDCA/Six Sigma).
• Partner with quality, maintenance, and engineering to keep workflow smooth.
• Conduct detailed process analyses to identify waste and inefficiencies.
• Facilitate workshops, training, and brainstorming on lean tools.
• Implement SOPs and best practices across departments.
• Track and report KPIs to senior management.

Skills

Lean transformation

5S

Value stream mapping

Kanban

Six Sigma

Analytical skills

Education

Bachelor's degree in Engineering

Master’s degree in Operations Management

Tools

Visio

Minitab

Job description

Responsible and accountable for continuous improvement and efficiencies across the Company’s products, systems, operations and processes.

Working with the Senior Management Team, develop, set the pace, and implement business transformational and continuous improvement strategy with sensitivity towards the organizational structure, commercial approach, culture, people, and processes according to the Harland Lean Operation System. Outline direction and deployment of the Lean framework to ensure consistent and rigorous application across the business in line with best practice

Customer focus: This role will lead continuous improvement initiatives and embed lean principles across operations. This role will drive process optimization, eliminate waste, and foster a culture of continuous improvement according to customer expectations.

Develop, train, and ingrain the Harland Continuous Improvement Methodology

Key Responsibilities:

• Support the development of a strategic roadmap for lean transformation and evaluate the effectiveness of implemented changes.
• Work to improve workplace organization and operational efficiency, including 5S implementation.
• Align with management to integrate lean initiatives with business objectives and customer needs.
• Lead Kaizen events to promote small, incremental changes across teams.
• Stay updated on industry trends and best practices in lean management
• Problem Solving: Identify operational bottlenecks, track scrap reduction, and apply root-cause analysis (such as PDCA or Six Sigma methods) to fix issues quickly
• Cross-Functional Work: Partner with quality, maintenance, and engineering groups to keep workflow smooth and equipment functional
• Conduct detailed process analyses of current workflows to identify waste, operational inefficiencies, and alignment with lean principles.
• Facilitate workshops, training, and brainstorming sessions on lean tools and frameworks.
• Implement standard operating procedures (SOPs) and best practices across departments based on lean principles.
• Track and report key performance indicators (KPIs) to assess process improvement success and present them to senior management.

Required Qualifications:

• A Bachelor’s degree in Engineering, Business Management, Operations, or similar.
• 5+ years of experience in a lean change agent role within a company.
• Experience with lean in a medical device and regulated environment, especially when implementing SOPs in an FDA-regulated environment
• Strong leadership skills to drive organizational change and engage teams.
• Proficiency in process improvement frameworks and lean methodologies/tools like 5S, Value Stream Mapping, Kanban, and Six Sigma.
• Hands-on experience in project and change management with a track record of delivering measurable results.
• Strong analytical skills to interpret data and identify improvement opportunities.
• Excellent communication and leadership abilities to influence teams and stakeholders.
• A results-driven mindset with a focus on measurable outcomes.
• Strong commitment to fostering a culture of continuous improvement.
• Familiarity with manufacturing, logistics, or service industry workflows

Preferred Qualifications:

• Master’s degree in Operations Management or a related discipline.
• Relevant certification in Six Sigma (Green Belt/Black Belt) or Lean Management.
• Proficiency in process mapping software and tools (e.g., Visio, Minitab).
• Knowledge of agile methodologies or frameworks.
• Qualified Trainer is advantageous
• Ability to manage multiple projects in a dynamic environment.
• Strong facilitation skills for conducting workshops and Kaizen events.
• Knowledge of data analytics tools to measure and interpret performance metrics.
• Knowledge of regulatory standards such as ISO, FDA, or GMP (as applicable).

Working Conditions and Health & Safety:

• Heated and air-conditioned office environment, ISO Class 7 Cleanroom, Laboratory.
• Employee is required to use appropriate PPE including, but not limited to, nitrile or latex gloves, lab coat, hair bonnet, shoe covers, beard cover, safety glasses, hearing protection, face shield, or respiratory mask while working in a lab or manufacturing space

Harland Medical System's commitment to ensure employee health and safety is a priority. Personnel engaged in manufacturing shall obtain training required by ISO 13485, FDA 21 CFR part 820, FDA 21 CFR part 210 & 211, and Harland Medical System's internal procedures, where deemed appropriate per assigned job functions.