Lean Process Engineer
Cincinnati, Ohio, États-Unis ● Mason, Ohio, États-Unis
Numéro de demande 2118
7 octobre 2024
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.
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Autres détails
- Famille d'emplois Process Engineering
- Fonction professionnelle Operations
- Type de paie Salaire
- Indicateur d'emploi Non Manager