POSITION SUMMARY:

The Process Engineer is responsible for on-going production, validations, and continuous improvement of new and existing manufacturing processes.  They contribute in a creative and collaborative way to achieve the company’s goals of producing market leading products through positive patient outcomes.

 

ESSENTIAL FUNCTIONS OF THE POSITION:

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

Ownership of product assembly line technical performance.  Support production with troubleshooting assembly line issues, resolution of non-conformances, completion of root cause investigations, and CAPA’s  Drive a lean, KPI-driven, and continuous improvement culture across the department Implement lean principles and methodologies to optimize manufacturing processes. Lead continuous improvement initiatives, including value stream mapping (VSM), 5S and Kaizen events Analyze production data to identify bottlenecks, inefficiencies, and opportunities for streamlining 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 Act as a lean champion to train and mentor others on lean concepts and tools as needed

 

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 judgement 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 over 50 pounds Ability to pass pre-employment drug screen and background check

 

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