Lean Process Engineer

POSITION SUMMARY:

The Lean Process Engineer is responsible for driving a lean, KPI driven and continuous improvement culture across the department. This role will implement lean principles and methodologies to optimize the manufacturing processes.

ESSENTIAL FUNCTIONS OF THE POSITION:

Team member of projects involving design and manufacturing resources, both internal and external.  Specific expectations include:

• Lead continuous improvement initiatives, including value stream mapping (VSM), 5S and Kaizen events.
• Analyze production data to identify bottlenecks, inefficiencies, and opportunities for streamlining
• Act as a lean champion to train and mentor others on lean concepts and tools as needed.
• Collaborate with cross-functional engineering team (quality, product development, regulatory) to

address product line issues

• Responsible for communication of manufacturing and process issues to cross functional engineering team and suppliers, both verbally and in written documentation
• Review of proposed component tolerances and input to manufacturing capability 
• Has knowledge of tolerance capabilities of machining, molding, casting, stamping, forming, grinding, etc. 
• Understands GD&T and how to properly apply it to yield the desired fits between joining parts
• Review of proposed device assembly requirements and identification of Design for Assembly opportunities.  Understanding of assembly and joining techniques including laser welding, ultrasonic welding, adhesive bonding, over-molding, soldering etc.  Understand of error proofing, poke-yoke
• Working knowledge of Manual and Automated Assembly Systems and Technologies
• Support the product assembly line technical performance.  Support production with troubleshooting assembly line issues, resolution of non-conformances, completion of root cause investigations, and CAPA’s 

MANUFACTURING PROCESS KNOWLEDGE

• Knowledge of general manufacturing technologies (plastic injection molding, stamping, milling, turning, assembly methods, various fastening techniques) including low to medium volume manufacturing processes
• Familiar with manufacturing efficiency strategies such as Lean, Six Sigma, 5S, Value Stream mapping, using SPC in resolving/improving productivity and efficiencies etc.
• Work with outside suppliers to define, document, analyze and qualify their manufacturing processes.
• Identify new vendors, processes, materials, and technologies that can be used to improve product quality and reduce product cost
• Identify and implement manufacturing and product-related cost reduction opportunities.  Understand life cycle costs and cost benefit analysis. Apply continuous improvement methods to enhance yield, consistency, performance, capacity, etc. of equipment and processes
• Perform process capability assessments and establish methods to control process output.
• Working understanding of quality statistical models and metrics (confidence/reliability intervals, DOE, regression/trending, SPC, t-Tests, acceptance plans)
• Able to work in a controlled environment where gowning and strict adherence to clean room procedures are required.

TOOLING AND EQUIPMENT

• Able to define, communicate, and develop fixture concepts using internal and external resources. Able to incorporate the capabilities of typical production association into these concepts.
• Work with designers and engineers in the design and development of manufacturing-related equipment and fixtures. 
• Define and track project tooling and equipment schedule and cost.
• Responsible for proper installation of new equipment and setting up proper preventive maintenance and calibration plans.
• Working knowledge of Manual and Automated Assembly Systems and Technologies, including both mechanical and control systems
• Experienced with mechanical equipment and gauges such as microscopes, soldering stations, ovens/furnaces, UV curing stations, Instron, calipers and other measurement gauges.

VERIFICATION AND VALIDATION

• Responsible for developing detailed process qualification strategies.
• Able to define statistical sample sizes as related to variable and attribute data based on established company and industry standards.
• Responsible for maintaining and updating Process maps and FMEAs.
• Responsible for writing and executing process qualification protocols and reports.
• Understanding of Test Method Validation, IQ, OQ, PQ approach as defined by AtriCure Quality System

MANUFACTURING LOGISTICS

• Understand supply chains, lead times, and raw material availability.
• Able to construct Bills of Material, with proper unit of measure and inventory points.
• Working knowledge of MRP and other requirement planning systems
• Able to conduct time studies and analyze cost variances.

TROUBLESHOOTING AND ROOT CAUSE ANALYSIS

• Responsible for evaluating components for conformance to design intent via inspection and functional evaluation.
• Responsible for trending scrap and failure rates, analyzing failure modes, and developing plans to address root cause issues.
• Responsible for supporting ongoing manufacturing on a daily basis to allow them to meet required production goals.
• Responsible for disposition of non-conforming material

DOCUMENTATION

• Properly document all work in compliance with AtriCure Quality System requirements
• Responsible for process documentation release using tools such as Visio, Excel, Word, Procal and Master Control documentation release systems.
• Write detailed, easy to understand process instructions.
• Write detailed test protocols and reports to document qualification activities.

ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:

• Regular and predictable worksite attendance
• Ability to work under fast-paced conditions.
• Ability to make decisions and use good judgment.
• Ability to prioritize various duties and multitask as required.
• Ability to successfully work with others.

• Additional duties as assigned.

BASIC QUALIFICATIONS:

• Bachelor’s degree in engineering (mechanical, industrial, or related field) required or demonstrated equivalent combination of education, training, and experience.
• 3 + years of relevant experience
• Demonstrated Mechanical and/or Process Engineering ability.
• Solid understanding of external standards, design controls, quality controls, manufacturing methods
• Demonstrates the ability to plan and track tasks to align with project plan and team objectives.
• Demonstrates excellent written and oral communication skills.
• Demonstrates excellent ability to work on and influence cross functional teams.
• Demonstrated ability with data analysis, problem-solving, and troubleshooting.
• Capable of prioritizing tasks and provide a timely schedule of completion.
• Ability to travel 5%

PREFERRED QUALIFICATIONS:

• Medical device industry experience
• Lean Six Sigma certification (Green Belt (or) Black Belt)
• Demonstrated lean manufacturing process implementation experience.
• Proficiency in lean tools such as 5S, Kanban, VSM etc.
• Solid understanding of Industry regulations as it pertains to medical devices.
•  

OTHER REQUIREMENTS:

• Ability to regularly walk, sit, or stand as required.
• Ability to occasionally bend and push/pull.
• Ability to regularly lift up to 10 pounds, occasionally lift up to 50 pounds.
• Ability to pass pre-employment drug screen and background check.

#LI-RW1