Associate Process Engineer

AtriCure • Mason, OH

9d

About The Position

POSITION SUMMARY:The Associate 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 ways 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, manufacturing, and quality resources, both internal and external. Specific expectations include: Support 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.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 processesIdentify new vendors, processes, materials, and technologies that can be used to improve product quality and reduce product costIdentify 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 conceptsWork with designers and engineers in the design and development of manufacturing-related equipment and fixtures. Define and track project tooling and equipment schedule and costResponsible 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 systemsExperienced with mechanical equipment and gauges such as microscopes, soldering stations, ovens/furnaces, UV curing stations, Instron, calipers and other measurement gauges. Verification and Validation Supporting 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 availabilityAble to construct Bills of Material, with proper unit of measure and inventory pointsKnowledge of MRP and other requirement planning systemsAble 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 evaluationResponsible for trending scrap and failure rates, analyzing failure modes, and developing plans to address root cause issuesResponsible for supporting ongoing manufacturing on a daily basis to allow them to meet required production goalsResponsible for disposition of non-conforming materialProperly document all work in compliance with AtriCure Quality System requirementsResponsible for process documentation release using tools such as Visio, Excel, Word, Procal and Master Control documentation release systemsWrite detailed, easy to understand process instructionsWrite detailed test protocols and reports to document qualification activities ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION: Regular and predictable work performanceAbility to work under fast-paced conditionsAbility to make decisions and use good judgmentAbility to prioritize various duties and multitask as requiredAbility to successfully work with othersAdditional duties as assigned

Requirements

• Bachelor’s degree required or demonstrated equivalent combination of education, training and experience.
• 0-7 years of relevant experience.
• Able to assist the lead engineer for process improvement projects with minimal guidance
• Demonstrated Mechanical and/or Process Engineering ability.
• 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.

Nice To Haves

• Medical device industry experience
• Validation experience
• Understanding of Industry regulations as it pertains to medical devices
• Graduate degree
• Assembly and machining experience
• Regulatory experience
• Statistical use experience
• Engineering/design background
• Financial analysis experience

Responsibilities

• Team member of projects involving design, manufacturing, and quality resources, both internal and external.
• Support 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.
• Review of proposed device assembly requirements and identification of Design for Assembly opportunities.
• 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.
• 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 maintaining and updating Process maps and FMEAs.
• Responsible for writing and executing process qualification protocols and reports.
• 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 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

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 1,001-5,000 employees