Job Description
Senior Process Engineer
Cincinnati, OH, USA * Mason, OH, USA
Req #1952
Tuesday, February 20, 2024
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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Other details
Job Family
Process Engineering
Job Function
Operations
Pay Type
Salary
Employment Indicator
Non Manager
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All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, protected veteran status or status as an individual with disability.
