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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