Process Engineer

Job Description

POSITION SUMMARY:

The Process Engineer is responsible for on-going production, validations, and continuous improvement of new and existing manufacturing processes. He/she contributes 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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