Process Engineer

AtriCure • Mason, OH

4d • Onsite

About The Position

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.

Requirements

• 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%
• 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

Nice To Haves

• 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

Responsibilities

• 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
• Review of proposed device assembly requirements and identification of Design for Assembly opportunities.
• Act as a lean champion to train and mentor others on lean concepts and tools as needed
• 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.
• 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.
• Able to define, communicate, and develop fixture concepts using internal and external resources.
• 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
• 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
• Understand supply chains, lead times, and raw material availability
• Able to construct Bills of Material, with proper unit of measure and inventory points
• Able to conduct time studies and analyze cost variances
• 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
• 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
• 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

Benefits

• Medical & Dental beginning day 1 of employment
• 401K plus match
• 30 days of paid Parental Leave, in addition to maternity leave, for new moms and dads
• Volunteer Time off
• Pet Insurance
• On-site fitness center
• On-site cafeteria

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level