Process Engineer

Atricure, Inc. - Cincinnati, OH

Posted: 3/9/2024 - Expires: 6/7/2024

Job ID: 270808377

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Job Description

Process Engineer

Cincinnati, OH, USA * Mason, OH, USA
Req #1969

Friday, March 1, 2024

AtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions. Afib affects more than 33 million people worldwide. Electrophysiologists and cardiothoracic surgeons around the globe use AtriCure technologies for the treatment of Afib and reduction of Afib related complications. AtriCure's Isolator Synergy Ablation System is the first medical device to receive FDA approval for the treatment of persistent Afib. AtriCure's AtriClip Left Atrial Appendage Exclusion System products are the most widely sold LAA management devices worldwide. AtriCure's Hybrid AF Therapy is a minimally invasive procedure that provides a lasting solution for long-standing persistent Afib patients. AtriCure's cryoICE cryoSPHERE probe is cleared for temporary ablation of peripheral nerves to block pain, providing pain relief in cardiac and thoracic procedures. For more information, visit AtriCure.com or follow us on Twitter @AtriCure.

We foster a culture of inclusion by embracing diverse experiences and individuals where everyone's authentic self is welcome. We offer supporting programs and resources that provide enriching and equitable opportunities for each person to contribute professionally and personally.

AtriCure, Inc. provides innovative technologies for the treatment of Atrial Fibrillation (Afib) and related conditions. Afib affects more than 33 million people worldwide. Electrophysiologists and cardiothoracic surgeons around the globe use AtriCure technologies for the treatment of Afib and reduction of Afib related complications. AtriCure's Isolator Synergy Ablation System is the first and only medical device to receive FDA approval for the treatment of long standing persistent Afib. Additionally, our AtriClip Left Atrial Appendage (LAA) Exclusion System products are the most widely used LAA management devices worldwide. For more information, visit AtriCure.com or follow us on Twitter @AtriCure.

POSITION SUMMARY:

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.

ESSENTIAL FUNCTIONS OF THE POSITION:

Team member of projects involving design and manufacturing resources, both internal and external. Specific expectations include:

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
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
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 worksite attendance
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 required or demonstrated equivalent combination of education, training and experience
5-7 + 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 required
Ability to occasionally bend and push/pull
Ability to regularly lift up to 10 pounds, occasionally lift up to 50 pounds
Ability to pass pre-employment drug screen and background check

#LI-RW1

AtriCure has a variety of benefits available for US based employees and their families. Examples include Medical & Dental beginning day 1 of employment, 401K plus match, 20 days of paid Parental Leave, in addition to maternity leave, for new moms and dads, Volunteer Time off, Pet Insurance, and more. Corporate-based employees also have full access to our on-site fitness center and cafeteria. To see a complete list of our benefits, please visit our careers website: https://www.atricure.com/benefits AtriCure participates in the federal E-Verify program to confirm the identity of and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here https://www.e-verify.gov/ AtriCure is an Equal Employment Opportunity/Affirmative Action employer and provides Drug Free Workplaces. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national or ethnic origin, age, protected veteran status, status as an individual with disability, sexual orientation, gender identity or any other characteristic protected by federal, state, or local law(s).

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.

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Job Summary

Employment Type:: Full Time Employee
Job type:: Federal Contractor
Skill Based Partner:: No
Education Level:: Bachelor's degree
Work Days:: Mon, Tue, Wed, Thu, Fri
Job Reference Code: 78534990
Salary: N/A
Licenses / Certifications:: N/A; Applied Math: 5; Graphic Literacy: 6; Workplace Documentation: 7

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Process Engineer

Atricure, Inc. - Cincinnati, OH

Job Description

Job Summary