Senior Process Engineer

POSITION SUMMARY:

The Senior 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 
• 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

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
• 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
• Familiar with manufacturing efficiency strategies such as Lean, Six Sigma, 5S, Value Stream mapping, using SPC in resolving/improving productivity and efficiencies etc.
• 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 work performance
• 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
• 7 + 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
• Demonstrated validation experience
• Solid understanding of Industry regulations as it pertains to medical devices

OTHER REQUIREMENTS:

• Ability to regularly walk, sit, or stand as needed
• Ability to occasionally bend and push/pull as needed
• Ability to pass pre-employment drug screen and background check

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